FDA
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug
Administration,
U.S. Public Health Service, Department of Health and Human Services. It contain
s
information
on actions taken in connection with agency regulatory activities.
ENFORCE
09/25/1996
ENFORCEMENT REPORT FOR 09/25/96
September 25, 1996 96-39
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Alsoy Soy Formula, concentrated liquid infant
formula, in 13 ounce cans. Recall #F-718-6.
CODE Code: 6150EWAC047 Note: Only the portion of
the lot with incorrect lids is being recalled.
These lids state "DO NOT ADD WATER" and are
written in English and French.
MANUFACTURER Nestle Food Company, Nutritional Products
Division, Eau Claire, Wisconsin.
RECALLED BY Nestle USA, Inc., Glendale, California, by
letter sent on August 16, 1996, and by press
release on August 20, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Maryland, Michigan, New York, New Jersey,
Pennsylvania, Virginia.
QUANTITY 2,764 cases (12 cans per case) were
distributed.
REASON A portion of this lot of concentrated infant
formula was manufactured with lids intended
for ready-to-feed formula. The potential
exists for a consumer to follow the lid
directions (DO NOT ADD WATER) and not properly
dilute the formula prior to feeding.
_______________
PRODUCT Chocolate Chip Cookie Dough Ice Cream, in 1
pint containers, distributed by Petersen's Old
Fashioned Ice Creams Company.
Recall #F-719-6.
CODE None.
MANUFACTURER Chocolate Shoppe Ice Cream Company, Inc.,
Madison, Wisconsin.
RECALLED BY Manufacturer, by telephone on August 2, 1996.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 60 pints were distributed.
REASON Product contains undeclared eggs.
_______________
PRODUCT Zurheide Das Beste brand Mackinac Island Fudge
Light Ice Cream, in half-gallon (1.89 L)
rounds. Recall #F-720-6.
CODE Date "1346" on bottoms of containers.
Zurheide item #44914.
MANUFACTURER Zurheide Ice Cream Company, Inc., Sheyboygan,
Wisconsin.
RECALLED BY Manufacturer, by visit beginning on July 25,
1996, and by visit July 25, 1996 - August 9,
1996. Firm-initiated recall complete.
DISTRIBUTION Wisconsin, Illinois.
QUANTITY 2,616 units were distributed.
REASON Product contains undeclared eggs.
_______________
PRODUCT Cookie Dough Ice Cream, in 1-1/2 gallon tubs,
for dipping, labeled All Natural Gelato Fresco
Ice Cream Italiano. Recall #F-721-6.
CODE JAN 23 1997.
MANUFACTURER Watermark Foods, Inc., Fairport, New York.
RECALLED BY Manufacturer, by letter dated August 7, 1996.
Firm-initiated recall complete.
DISTRIBUTION New York.
QUANTITY 24 tubs were distributed.
REASON Product contains undeclared eggs.
_______________
PRODUCT Chocolate Chip Cookie Dough Ice Cream, labeled
C.C. Cookiedough, in 3 gallon tubs.
Recall #F-722-6.
CODE G18F and G26F.
MANUFACTURER M.B.B. Annis Dairy of Avon, Inc., Avon,
New York.
RECALLED BY Manufacturer, by letter dated August 8, 1996.
Firm-initiated recall complete.
DISTRIBUTION New York.
QUANTITY 34 tubs were distributed.
REASON Product contains undeclared eggs.
_______________
PRODUCT Natures Touch Chocolate Chip Cookie Dough Ice
Cream in half-gallon plastic pails.
Recall #F-723-6.
CODE 10-19, 02-10, 04-03, 04-23.
MANUFACTURER Kwik Trip, Inc., La Crosse, Wisconsin.
RECALLED BY Manufacturer, by E-mail and press release on
July 25, 1996. A second electronic message
was sent on August 1, 1996. Firm-initiated
recall complete.
DISTRIBUTION Minnesota, Wisconsin, Iowa.
QUANTITY 4,343 containers were distributed; firm
estimated that 1,000 containers remained on
market at time of recall initiation.
REASON Product contains undeclared eggs.
_______________
PRODUCT Mrs. Wright's Chocolate Chip Cookies, 11.5
ounce cellophane bags. Recall #F-724-6.
CODE SEP1596NB and JAN197LB.
MANUFACTURER Safeway Stores Bakery Division, Joplin,
Missouri.
RECALLED BY Safeway, Inc., Pleasanton, California, by
press release on August 18, 1996, followed by
telephone. Firm-initiated recall ongoing.
DISTRIBUTION California, Oregon, Arizona, Colorado,
Maryland.
QUANTITY 1,573 cases (12 bags per case) of lot
SEP1596NB and 1,378 cases (12 bags per case)
of lot JAN197LB were distributed.
REASON Product contains undeclared peanuts or peanut
products.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Buena Vida Queso Blanco White Cheese and Queso
Para Freir Frying White Cheese sold in bulk
pieces weighing approximately 5 pounds, or in
random-weight, plastic-wrapped retail
packages, under the following labels:
Buena Vida Queso Blanco White Cheese, Buena
Vida Para Freir Frying Cheese, and Buena Vida
Queso Blanco White Frying Cheese, distributed
by Del Campo Foods;
Tut's Spanish Cheese, distributed by Tuts
International Export & Import Company;
Gold Star Village Cheese, distributed by Gold
Star Trading Corporation;
Goya Queso Blanco Del Pais White Cheese,
distributed by Goya Foods, Inc.;
Blue Cock Queso Blanco Gayo Azul Finest White
Cheese, distributed by Dutch Cheese Company.
Recall #F-616/617-6.
CODE All lots still in distribution.
MANUFACTURER Avonmore Cheese, Inc., Kent, Illinois.
RECALLED BY Avonmore Cheese, Inc., Monroe, Wisconsin, by
Firm-initiated recall complete.
DISTRIBUTION New Jersey, New York.
QUANTITY Approximately 36,000 pounds were on the market
at time of recall initiation.
REASON Product is unfit for food.
_______________
PRODUCT Various Fresh Pastas sold in bulk at the
retail counter: (a) Egg pasta; (b) Spinach
Pasta; (c) Red Chili Pasta; (d) Greek Ravioli,
(e) Cheese Ravioli; (f) Vegetable Ravioli; (g)
Cheese Tortellini; (h) Pesto Tortellini; (i)
Hazelnut Tortellini. Recall #F-725/733-6.
CODE None.
MANUFACTURER Pasta & Company, Seattle, Washington.
RECALLED BY Manufacturer, by Telephone on August 28, 1996.
Firm-initiated recall complete.
DISTRIBUTION Washington state.
QUANTITY Approximately 1,032 pounds were produced.
REASON Products manufactured using eggs which were
contaminated with salmonella.
_______________
PRODUCT Dow Corning 24 Emulsion, used as a mold
release agent in industrial applications and
also for mold release in the manufacture of
latex gloves. The product is also used as a
release agent in food related products. The
product is packaged in 2200 lb., 420 lb. and
40 lb. drums. Labeling for the product
indicates that the product meets FDA and
Kosher requirements for use as a release agent
lubricant and packaging aid in processing
products that may contact food.
Recall #F-734-6.
CODE All lots produced since 1993: GA085392,
GA105406, GA105409/417, GA115418,
GA115423/427, GA125429/430, GA125432,
GA016434/442, GA026444/450, GA026452,
GA026454/458, GA036459/461, GA036464/466,
GA046470, GA056473/474.
MANUFACTURER Dow Corning Corporation, Greensboro, North
Carolina.
RECALLED BY Dow Corning Corporation, Midland, Michigan, by
letter on May 20, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 51 lots were distributed.
REASON Product is contaminated with Pseudomonas
aeruginosa.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Quick Fix brand snacks in 3 ounce packages:
(a) All Fruit Mix; (b) Tropical Fruit Mix.
Recall #F-706\707-6.
CODE All product with "use by" dates on or prior to
July 14, 1996.
MANUFACTURER Snak King, City of Industry, California.
RECALLED BY Manufacturer, by letter dated March 3, 1995.
Firm-initiated recall complete.
DISTRIBUTION California, Connecticut, Indiana,
Massachusetts, Montana, North Carolina, New
Jersey, Oklahoma, Texas.
QUANTITY (a) 22 cases; (b) 31 cases (72 units per case)
were distributed; firm estimates none remains
on the market.
REASON Products contain undeclared sulfites.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Dilantin Kapseals (Extended Phenytoin Sodium),
USP, 100 mg, antiepileptic. Recall #D-266-6.
CODE Lot numbers: 05685F, 02595F (bottles of 100);
02895F, 012N5F, 00626F (bottles of 1000).
Recall #D-266-6.
MANUFACTURER Warner Lambert Company, Fajardo, Puerto.
RECALLED BY Warner-Lambert Company, Morris Plains, New
Jersey, by letter on August 12, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 40,403 bottles of lot 05685F, 40,320 bottles
of lot 02595F, 3,900 bottles of lot 02895F,
4,044 bottles of lot 012N5F, 3,879 bottles of
lot 00626F were distributed.
REASON Stability test dissolution failure.
_______________
PRODUCT Nitrostat (nitroglycerin, USP), 0.4 mg
Sublingual Tablets, in bottles of 25,
indicated for the prophylaxis, treatment and
management of patients with angina pectoris.
Recall #D-267-6.
CODE Lot #02415F.
MANUFACTURER Warner-Lambert Company, Fajardo, Puerto Rico.
RECALLED BY Parke-Davis, Division of Warner-Lambert
Company, Morris Plain, New Jersey, by letter
on August 13, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 22,817 bottles were distributed.
REASON Stability test assay failure.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Congess SR. (Guaifenesin, 250 mg;
Pseudoephedrine HCl, 120 mg) Capsules,
packaged in bottles of 100, Rx decongestant.
Recall #D-268-6.
CODE 6011467 EXP 9/96.
MANUFACTURER Fleming & Company, Fenton, Missouri.
RECALLED BY Manufacturer, by telephone on September 6,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 129 bottles were distributed.
REASON Stability test release rate failure.
_______________
PRODUCT Beta-HC 1/4% Topical Lotion (Hydrocortisone
Cream USP), antipruritic (anti-itch) lotion,
in 4 fluid ounce bottles. Recall #D-269-6.
CODE Lot KLA.
MANUFACTURER Beta Dermaceuticals, Inc., San Antonio, Texas.
RECALLED BY Manufacturer, by letter dated August 20, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,189 bottles were distributed; firm estimated
that 642 bottles remained on market at time of
recall initiation.
REASON FDA analysis found product to be subpotent.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Source Plasma. Recall #B-638-6.
CODE Unit numbers: DKU236, DKU499, DKU851.
MANUFACTURER Sera-Tec Biologicals, Inc., Fort Wayne,
Indiana.
RECALLED BY Manufacturer, by fax on November 11, 1992.
Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 3 units.
REASON Blood products were collected from a donor who
previously tested positive for syphilis.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Model 5000 Head Spring, a component used in
Invacare's Mobilite Full and Semi Electric Bed
Models 5410, 5310, 5210, 5110, 5307, 5207, and
5107. Recall #Z-1132-6.
CODE Serial Numbers range from 96A86596 to 96A87190
and from 96A01835 to 96A02976.
MANUFACTURER Invacare Corporation, Sanford, Florida.
RECALLED BY Manufacturer, by letter dated March 11, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,538 units were distributed with the
defective head springs.
REASON A rear weld on the center mounting latch of
the head spring can fracture during use.
_______________
PRODUCT Advantx LCA Angiography System, Model
#S5800YB, used for medical imaging during
general angiography and interventional
procedures. Recall #Z-1143-6.
CODE All serial numbers.
MANUFACTURER General Electric Company, Medical Systems
Division, Waukesha, Wisconsin.
RECALLED BY Manufacturer, by telephone on August 1, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 57 units were distributed.
REASON Failure of a gantry motor control board may
cause the gantry to move at unexpectedly high
speeds, which can result in a collision
between the gantry and the patient or
operator.
_______________
PRODUCT Cozy/Headrest Retaining Strap, Part #451220
and Posterior Headrest Pads, Part #450100 and
#450102. Recall #Z-1155/1156-6.
CODE None.
MANUFACTURER Quickie Designs, Inc., Fresno, California.
RECALLED BY Manufacturer, by letter dated July 19, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania, Illinois, Connecticut, Kansas,
Kentucky, Massachusetts, California, Texas,
Florida.
QUANTITY 184 straps were distributed.
REASON The strap of the headrest may slip down the
head of the user which could cause neck
strain, choking, or asphyxiation.
_______________
PRODUCT Laser Systems, used for cutting of process
material with focused laser radiation:
(a) Model LPL-103; (b) Model LPL-104;
(c) Model LPLS-001. Recall #Z-1157/1159-6.
CODE Models LPL-103, LPL-104, LPLS-001.
MANUFACTURER LPL Systems, Inc., Mountain View, California.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan September 10, 1996.
Firm-initiated field correction ongoing.
DISTRIBUTION New Jersey and Minnesota.
QUANTITY 7 units.
REASON Noncompliance with performance standards for
laser products in that the systems failed to
have the correct wording on warning
labels; the interlock switches failed to
included an indication of defeat; user
information failed to include required
information concerning the maximum output of
laser radiation and to include reproductions
of required warning labels.
_______________
PRODUCT Fresenius A 2008 Hemodialysis Systems:
(a) Model C Dialysis Delivery System
(b) Model D Dialysis Delivery System
(c) Model E Dialysis Delivery System.
Recall #Z-1160/1162-6.
CODE Type for all Models A 2008.
Serial number range of Hemodialysis System,
model C units involved in recall: 401A2026
through 701S6028 (units manufactured
1984-1987, inclusive)
Serial number range of Hemodialysis System,
model D units involved in recall: 671A0001
through 171SA065 (units manufactured
1986-1992, inclusive)
Serial number range of Hemodialysis System,
model E units involved in recall: 9EOS0001
through 9EOS0692 (units manufactured in 1989)
MANUFACTURER Fresenius AG (formerly called MTS), W.
Germany.
RECALLED BY Fresenius USA, Inc., Walnut Creek, California,
by letter April 15, 1996. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 796 units; (b) 4,537 units; (c) 992 units
were distributed.
REASON An increased resistance load on the power
supply coupled with a capacitor failure leads
to excess fluid removal.
_______________
PRODUCT Sterile procedural trays labeled as containing
x-ray detectable gauze. Recall #Z-1164/1191-6.
1. Dental Tray (50-2548)
2. Abdominal Tray (50-4267)
3. Total Hip Tray (50-5195) 151981
4. Ortho Pack 3 per case (50-6236)
5. C-Section Tray 5 per case (50-7664)
6. Abdominal Hysterectomy 4 per case
(50-7998)
7. Dr. Gallo Eye Tray (50-8191)
8. D & C Pack (50-8443)
9. Hand Pack (50-9473)
10. Carpal Tunnel Tray (50-10505)
11. Lap Chole Tray (50-10533)
12. Carotid Endarterectomy Tray (50-11133)
13. Vascular Tracecart (53-0168)
14. Dr. Bichlmeier Heart Tracecart (53-0474)
15. Laparoscopy Tracecart B (53-0551)
16. General Surgery Tracecart B (53-0552)
17. Hand Tracecart (53-0708)
18. Lap Chole Tracecart (53-0810)
19. Pediatric Tracecart II (53-1111)
20. Minor G.U. Tracecart (53-1116)
21. Major Abdominal Tracecart (53-1235)
22. ENT Tracecart I (53-1282)
23. Plastic/Oral Tracecart (53-1283)
24. Craniotomy Tracecart (53-1304)
25. Laparoscopic Tracecart (53-1344)
26. Arthroscopy Tracecart (53-1377)
27. Extremity Tracecart (53-1379)
28. Lap Cholecystectomy Basecart (53-2068)
CODE Product No. Lot No.
50-2548 154078
50-4267 150113
50-5195 151981
50-6236 149557
50-7664 152952, 154690
50-7998 154743
50-8191 151274
50-8443 152892
50-9473 148999
50-10505 151751
50-10533 148835
50-11133 149244
53-0168 157836, 159101
53-0474 152483
53-0551 155650, 157044
53-0552 157397, 158784
53-0708 158787
53-0810 155663
53-1111 157442
53-1116 156863
53-1235 158819
53-1282 156868
53-1283 157450
53-1304 157113, 158742
53-1344 158821
53-1377 158830
53-1379 158620
53-2068 157446.
MANUFACTURER DeRoyal Industries, Inc., Powell, Tennessee.
RECALLED BY Manufacturer, by telephone on August 12, 1996,
followed by letter August 13, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Connecticut, Delaware, Georgia, Indiana,
Kansas, New Hampshire, Oklahoma, Pennsylvania,
Utah, Illinois, Missouri, Ohio, New Jersey.
QUANTITY 446 cases were distributed.
REASON The devices may not contain X-Ray Detectable
gauze as labeled.
_________________
PRODUCT Terumo Hypodermic Needles:
(a) Terumo Hypodermic Needles, Product Code
3NN*1938R; (b) Terumo Hypodermic Needles,
Product Code 3NN*2038R; (c) Terumo Hypodermic
Needles, Product Code 3NN*2338R.
Recall #Z-1199/1201-6.
CODE Lot numbers: (a) UG0726; (b) UG1326;
(c) UG1426.
MANUFACTURER Terumo Medical Corporation, Elkton, Maryland.
RECALLED BY Manufacturer, by telephone and by fax,
followed by letter dated July 2, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 98,000 pieces were distributed.
REASON A hole was found in the bottom web where the
needle protector attaches to the needle hub,
therefore, compromising the sterility of the
product packaging.
_______________
PRODUCT Software Version 4.4.1 used in Triad, Biad,
Triad XLT, Biad XLT, and Monad Nuclear
Medicine Imaging Systems. Recall #Z-1203-6.
CODE All codes.
MANUFACTURER Trionix Research Laboratory, Twinsburg, Ohio.
RECALLED BY Manufacturer, by letter on August 16, 1996.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide, Belgium, England, Korea,
Australia, Egypt.
QUANTITY 202 systems were distributed.
REASON The computer software Version 4.4.1, which
controlled the movement of the gantry, was not
fully validated.
_______________
PRODUCT Vacu-Aide Suction Units, used as a portable
medical suction device for removal of fluids,
Distributed under DeVilbiss Health Care, Inc.
label:
(a) 7304A, Vacu-Aide Portable Suction Pump
(b) 7304D, Vacu-Aide AC Suction Pump
(c) 7304S, Vacu-Aide AC Suction Pump w/single
use bottle
Distributed under Laerdal Medical Corp. label:
(d) Model 880000; (e) Model 880001;
(f) Model 880002; (g) Model 880003;
(h) Model 880011. Recall #Z-1204/1211-6.
CODE Serial number range: (a) A30330 - A34099
(b) D21740 - D23815; (c) S1005 - S1769;
(d) 12694 - 12843; (e) 11911 - 12428;
(f) 2363 - 2450; (g) 1440 - 1464
(h) 2502 - 2551.
MANUFACTURER DeVilbiss Health Care, Inc., Somerset,
Pennsylvania.
RECALLED BY Manufacturer, by letter August 6, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 8,257 units were distributed.
REASON The piston rods may break during normal
operation, rendering the units unusable.
_______________
MANUFACTURER Stryker Endoscopy Hybrid Electrocautery Tip
and Spare Parts Kit:
Laproscopic Suction Irrigator & Electrosugical
Probe; (a) Catalog #250-070-422 - StrykeFlow
5 mm Suction/Irrigator Tip, 32 cm, Composite,
(Hybrid Tip) Endoscopy Hybrid Tip
(Electrocautery accessory to Suction
Irrigator, sold non-sterile)
(b) Catalog #250-070-430 - StrykeFlow Hybrid
Tip Spare Parts Kit (Hubs, O-rings, (Spare
Parts Kit) Sleeves) (sold non-sterile).
Recall #Z-1212/1213-6.
CODE Hybrid Tips (p/n 250-070-422) Lot #96049762
96059782; Hybrid Tip Spare Parts Kit (p/n
250-070-430) Lot # 96059782.
MANUFACTURER Stryker Endoscopy, Arroyo, Puerto Rico.
RECALLED BY Stryker Endoscopy, Santa Clara, California, by
voicemail sent May 31, 1996, followed by
letter June 10, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 261 hybrid tips and 8 boxes spare part kits
were distributed.
REASON The metal cannula may be exposed as a result
of shrinkage of the insulation sleeve
following autoclaving procedure, increasing
the opportunity for spurious electrocautery
discharge if the device is not properly
utilized.
_______________
PRODUCT Invacare Oxygen Concentrators Mobilaire III/V,
and Invacare III/V Oxygen Concentrators:
(a) Mobilaire III Oxygen Concentrator, Model
No. IRC301;
(b) Mobilaire V Oxygen Concentrator, Model No.
IRC501;
(c) Invacare III Oxygen Concentrator, Model
No. IRC 301O2, with optional Oxygen Purity
Indicator;
(d) Invacare V Oxygen Concentrator, Model No.
IRC 501O2, with optional Oxygen Purity
Indicator. Recall #Z-1216/1219-6.
CODE Serial Nos. 96B46257 - 96B46706,
96B99247 - 96B99265 and 96B50320 - 96B50916.
MANUFACTURER Invacare Corporation, Sanford, Florida.
RECALLED BY Manufacturer, by telephone on March 8, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 122 units were distributed.
REASON Kinked oxygen transfer hoses in the units
caused by defective exterior foam insulation
may affect the flow of oxygen, and therefore,
affect the concentration of oxygen the patient
receives.
_______________
UPDATE Recall #Z-1101/1102-6, Mobile\Portable General
Purpose Units, Models HP200 and HP300, which
appeared in the September 18, 1996 Enforcement
Report should read:
RECALLED BY: MinXray, Inc., Northbrook,
Illinois. Firm-initiated field correction has
not started.
_______________
UPDATE Bactec Instrument 460 TB Drug Susceptibility
Testing Instructional Manual, Recall #Z-1144-6
which appeared in the September 18, 1996
Enforcement Report should read: Firm-
initiated recall complete. QUANTITY:
Approximately 657 manuals were distributed in
May 1995.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Render-Plan 3-D Treatment Planning System,
computer programs intended for planning of
radiotherapy procedures. Recall #Z-1146-6.
CODE All systems.
MANUFACTURER Precision Mathematics, Inc., Columbia,
Maryland.
RECALLED BY Manufacturer, by issuing a Product Warning
Bulletin on or about February 22, 1996. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 100 units were distributed.
REASON Software errors may cause hard copy errors
when drawing the beam edges, when an aperture
is present.
_______________
PRODUCT Render-Plan 3-D Treatment Planning System,
computer programs intended for planning of
radiotherapy procedures. Recall #Z-1147-6.
CODE All systems.
MANUFACTURER Precision Mathematics, Inc., Columbia,
Maryland.
RECALLED BY Manufacturer, by issuing a Product Warning
Bulletin on or about May 2, 1996. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 100 units.
REASON Software errors in the irregular field program
may cause unexpected results.
_______________
PRODUCT Render-Plan 3-D Treatment Planning System,
computer programs intended for planning of
radiotherapy procedures. Recall #Z-1148-6.
CODE All systems.
MANUFACTURER Precision Mathematics, Inc., Columbia,
Maryland.
RECALLED BY Manufacturer, by letter dated December 28,
1995. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 100 units.
REASON Unexpected computational results due to
software errors.
_______________
PRODUCT Electron Microscopes, used for visualization
of microscopic objects:
(a) Philips SEM 515
(b) Philips SEM 525
(c) Philips SEM 535
(d) Philips SEM 545
(e) Philips XL20
(f) Philips XL30
(g) Philips XL40. Recall #Z-1192/1198-6.
CODE Model Numbers: Philips SEM 515, Philips SEM
525, Philips SEM 535, Philips SEM 545, Philips
XL20, Philips XL30, Philips XL40.
MANUFACTURER Philips Electronic Instruments Company,
Mahwah, New Jersey.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action on August 21, 1996. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 128 units.
REASON Under unlikely circumstances, the leakage
specification for x-radiation is exceeded.
_______________
PRODUCT Model 5348 Single Chamber Temporary Pacemakers
(AAI/VVI). Recall #Z-1214-6.
CODE All units sold prior to June 1, 1996.
MANUFACTURER Medtronic Milaca, Inc., Milaca, Minnesota.
RECALLED BY Medtronic, Inc., Minneapolis, Minnesota, by
telephone beginning on August 19, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,381 units were distributed.
REASON The keypad shorts can result in device
failure. The effects of failure can be that
the device will not turn on, the device turns
itself on or off, or rapid atrial pacing is
spontaneously initiated.
_______________
PRODUCT Lifepak 10 Defibrillator/Monitor/Pacemaker.
Recall #Z-1215-6.
CODE Serial numbers: 39808, 39809, 39810, 39811,
39813, 39814, 39816, 39818, 39820, 39821,
39823, 39829, and 39830.
MANUFACTURER Physio Control Corporation, Redmond,
Washington.
RECALLED BY Manufacturer, by issuing technical Service
Update (TSU) 196 and by visit beginning August
7, 1996. Firm-initiated field correction
complete.
DISTRIBUTION Iowa, Massachusetts, North Carolina, New York,
Ohio, Pennsylvania, Rhode Island, Wisconsin.
QUANTITY 13 units were distributed.
REASON There is potential for pacing function to
cease operation.
-15-
END OF ENFORCEMENT REPORT FOR SEPTEMBER 25, 1996. BLANK PAGES MAY FOLLOW.
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