Acuson S2000 Ultrasound System with software and imaging. The Acuson S2000 ultrasound imaging systems are intended for t
FDA device recall Z-1832-2011 · posted 2011-03-28 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- "Any 2D measurement performed in Exam Review or offline, on a zoomed Retrospective clip capture may be erroneous. This applies to 2D, 2D/PW, 2D/CW and 2D/M-mode."
- Action taken
- Siemens Medical Solutions USA, Inc. sent a Consumer Safety Advisory Notification letter on February 16, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to pass the Customer Safety Notice to all those within their organization who need to be aware of the issue until the corrective action was completed. For questions regarding this recall call 650-694-5580.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 1903
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of United Arab Emirates, Australia, Belgium, Bolivia, Brazil, Bahamas, Canada, Switzerland, Chile, China, Colombia, Czech Republic, Germany,
- Date initiated
- 2010-03-01
- Date posted
- 2011-03-28
- Date terminated
- 2012-06-18
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM (K093812) | Siemens Medical Solutions USA, Inc. | 2010-03-03 |