Acuson CV70 Ultrasound systems Ultrasonic Pulsed echo/doppler imaging system with Software revisions less than 4.0.0b, m
FDA device recall Z-2212-2008 · posted 2008-09-19 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- System may either display incorrect mechanical and thermal index values, or fail to display them altogether.
- Action taken
- Recall initiated on 06/04/2008. Under the Siemens update program, all consignees will receive a visit from Siemens service personal to install the revised software version. Siemens staff will coordinate with foreign distributors to arrange for service abroad.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 1230 units
- Distribution
- Worldwide Distribution.
- Date initiated
- 2008-06-04
- Date posted
- 2008-09-19
- Date terminated
- 2010-12-20
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM (K050240) | Siemens Medical Solutions USA, Inc. | 2005-02-15 |
| MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM (K042770) | Siemens Medical Solutions USA, Inc. | 2004-10-20 |
| ACUSON CV70 CARDIOVASCULAR SYSTEM (K042044) | Siemens Medical Solutions USA, Inc. | 2004-08-13 |
| ACUSON CV70 CARDIOVASCULAR SYSTEM (K032111) | Siemens Medical Solutions USA, Inc. | 2003-07-18 |