ACUSON Antares 5.0 ultrasound system at SW revision 200.0.054 or 200.0.059A, with one of the following options installed
FDA device recall Z-1766-2008 · posted 2008-09-02 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- Software issue may result in distorted images and inaccurate measurements, which could lead to a misdiagnosis.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 488 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,
- Date initiated
- 2008-03-21
- Date posted
- 2008-09-02
- Date terminated
- 2009-09-30
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM (K063803) | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007-01-05 |