Date Recall Initiated |
January 18, 2008
|
Date Posted |
September 01, 2008
|
Recall Number |
Z-1749-2008
|
Product |
UBiT?-IR300 Infrared Spectrophotometer, Software Versions 7.0, 7.01 and 7.11.
|
Code Information |
300292
300427
300129
300159
300502
300055
300378
300586
300262
300326
300219
300239
300356
300339
300318
300439
300511
300547
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300672
300697
300699
300460
300633
300004
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300531
300344
300525
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300597
300644
300303
300662
300208
300606
300389
300381
300281
300594
300247
300061
300534
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300602
300616
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300541
300176
300283
300409
300050
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300072
300105
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300086
300182
300375
300342
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300429
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300601
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300071
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300217
300178
300703
300175
300025
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300059
300168
300437
300017
300641
300416
300570
300348
300268
300467
300325
300202
300684
300266
300497
300114
300398
300155
300560
300637
300676
300073
300704
300705
300698
300204
300696
300316
300604
300665
300367
300695
300211
300232
300581
300611
300457
300308
300229
300490
300227
300162
300180
300286
300371
300504
300651
300515
300079
300317
300512
300170
300104
300106
300571
300465
300625
300666
300068
300088
300293
300003
300327
300430
300028
300070
300022
300011
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300257
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300223
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300632
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300393
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300639
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300716
300158
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300138
300089
300121
300244
300551
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300263
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300370
300153
300493
300345
300619
300116
300195
300163
300418
300146
300562
300181
300198
300174
300240
300333
300613
300313
300051
300557
300669
300670
300295
300673
300113
300614
300246
300635
300568
300190
300710
300302
300213
300322
300361
300595
300309
300186
300026
300408
300667
300572
300555
300536
300054
300341
300362
300593
300455
300569
300346
300394
300260
300640
300659
300464
300582
300446
300112
300624
300323
300205
300160
300658
300005
300179
300528
300654
300462
300224
300349
300415
300626
300014
300469
300486
300553
300565
300016
300314
300452
300407
300123
300396
300152
300623
300494
300527
300664
300561
300142
300717
300706
300709
300564
300649
300585
300269
300127
300133
300009
300234
300321
300255
300397
300406
300417
300400
300529
300267
300587
300366
300600
300335
300612
300067
300643
300008
300136
300605
300711
300499
300384
300475
300584
300256
300607
300216
300085
300183
300134
300143
300474
300392
300310
300278
300130
300628
300093
300575
300097
300609
300424
300444
300702
300701
300708
300117
300047
300215
300470
300690
300556
300466
300567
300387
300154
300007
300682
300687
300353
300184
300434
300689
300012
300686
300035
300700
300013
300191
300029
300549
300340
300091
300448
300487
300226
300139
300636
300610
300271
300228
300312
300249
300137
300092
300080
300185
300020
300668
|
Recalling Firm/ Manufacturer |
Otsuka America Pharmaceutical, Inc.
2440 Research Blvd
Rockville
, Maryland
20850-3238
|
For Addition Information Contact |
OAPI-Meretek
888-637-3835
|
Reason For Recall |
Medical device power supply may overheat and cause smoke to be emitted from the device.
|
Action |
The initial distributor in the US notified consignees 03/14/08 and 03/26/08 by letter. Consignees were provided two different letters depending on the hours of use of the spectrophotometer. The notifications advised of the firm's preventive service and upgrade program for the instrument's power supply, in which consignees would receive a temporary replacement instrument while the service is completed. Consignees with spectrophotometers having <15000 light source hours were notified similarly, and were provided filters and instructions for cleaning and replacing the filters to protect the power supply from unnecessary accumulation of debris. Contact firm at 1-888-MERETEK for assistance.
|
Quantity in Commerce |
463 units
|
Distribution |
The affected medical devices were distributed to medical facilities and physician offices nationwide and to distributors in Mexico.
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