syngo Imaging, picture archiving and communications system. Model number 7502029
FDA device recall Z-0070-2007 · posted 2006-10-25 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Potential issue with annotation function. Annotations, shown as overlays, may change font size when the image is saved. Text may appear shifted, or lines appear thicker, and their position may not be as intended.
- Action taken
- The recalling firm has issued a Customer Safety Advisory via certified mail to affected customers per Update Instructions HS096/06/S and HS097/06/S. The letter, dated September 5, 2006, informs customers of this issue and provides recommendations to avoid its occurrence.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 1818 units total, for all three products
- Distribution
- The product was shipped to medical facilities nationwide.
- Date initiated
- 2006-09-05
- Date posted
- 2006-10-25
- Date terminated
- 2008-09-17
- Location
- Malvern, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO IMAGING VERSION V20A (K052461) | Siemens AG Medical Solutions | 2005-09-22 |