Siemens syngo Dynamics 5.0 Workplace. Medical image report and archive system.
FDA device recall Z-0652-2007 · posted 2007-03-28 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions, USA, Inc
- Reason for recall
- The cardiac calculation feature may incorrectly calculate a derived V max value (reported out lower than it should be) and certain values imported into worksheets and reports may be incorrect due to a software defect.
- Action taken
- Distributors were issued a recall letter dated 1/29/07 and asked to notify their customers by issuing their subaccounts a similar letter. When available, new software will be provided.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 71
- Distribution
- Nationwide.
- Date initiated
- 2007-01-31
- Date posted
- 2007-03-28
- Date terminated
- 2008-04-30
- Location
- Ann Arbor, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO DYNAMICS, VERSION 5.0 (K053133) | Siemens Medical Solutions USA, Inc. | 2005-12-05 |