|
Medical Device Recalls
Class 3 Recall
Sonoline Antares 5.0 ultrasound system
|
|
Date Recall Initiated |
March 21, 2008
|
Date Posted |
September 02, 2008
|
Recall Number |
Z-1767-2008
|
Product |
Sonoline Antares 5.0 ultrasound system at SW revision 200.0.054 or 200.0.059A, with one of the following options installed: 3-Scape Imaging, Factory, PN 05937011 or 3-Scape Imaging, Field Upgrade, PN 07472520. Material number 5936518, 8653771 or 10037593
|
Code Information |
serial numbers 10163
10524
11148
11149
11150
110920
111158
111270
111287
111377
111389
111514
111558
111584
111712
111871
112317
112322
112388
112809
10188001
10437001
10566001
10604001
10669001
11008001
11047001
111552001
111692001
112081001
112081002
112087001
112089001
112117001
112178001
112182001
112306001
112360001
112384001
112554001
112597001
112697001
112704001
112743001
112744001
112776001
112859001
10722
111456
112288
112608
|
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc.
1230 Shorebire Way
P.O. Box 7393
Mountain View
, California
94043
|
Reason For Recall |
Software issue may result in distorted images and inaccurate measurements, which could lead to a misdiagnosis.
|
Action |
The firm initiated a field correction on 03/21/2008. Site visits to correct the problem and install the revised software version 200.0.063A are planned for all consignees. No other notification was made. The firm can be contacted at 650-694-5993.
|
Quantity in Commerce |
51 active units total
|
Distribution |
Product was distributed worldwide to 539 consignees, in the USA to MD, SC, AZ, FL, IL, WI, NJ, NC, CA, OH, VA TX, PA MO, NH, IA, NE, MN, NY, GA, MI, WA, HI, MA, SC, WV, VA, ND, IN, WY, UT, MS, TN, PR, SD, KY, OK, OR, and worldwide to Sweden, Saudi Arabia, Austria, New Zealand, Italy, Switzerland, Mexico, Germany, Australia, Canada, Great Britain, France, China, South Korea, Singapore, Denmark, Brazil, Poland, Norway, Faroe Islands, South Africa, Russian Federation, Romania, Trinidad and Tobago, Greece, India, Spain, Thailand, Ukraine, Nicaragua, Japan, India, Czech Republic, Egypt, Taiwan, Turkey, Malaysia, Qatar, Bosnia an dHerzogovina, Vietnam, Brunei Darussalam, Italy, Kuwait, Turkey, Portugal
|
|
|
|
|
|