Siemens brand ACUSON S2000 Ultrasound System with software versions: VA10, VA10A, VA10B, VA10C, VA15; Model Number: 1004
FDA device recall Z-1900-2011 · posted 2011-04-06 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- The product has a software problem in which previous patient measurement data gets associated with another patient's image.
- Action taken
- The firm, SIEMENS, issued a "CUSTOMER SAFETY ADVISORY NOTIFICATION" letter to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that the first image in Exam Review is from the current patient; ensure that the Heart Cycle measurement tool is not selected on the Cale menu when entering Exam Review; be aware of this issue as described in the letter and perform four (4) or less measurements of the same measurement label. Should you have any questions, please call (650) 694-5398.
- Root cause
- Software change control
- Status
- Terminated
- Product code
- GKZ
- Distribution
- Worldwide distribution.
- Date initiated
- 2009-01-14
- Date posted
- 2011-04-06
- Date terminated
- 2011-04-06
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM (K082142) | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2008-11-13 |