syngo Imaging Version V31 Picture Archiving and Communication System, model number 10014063.
FDA device recall Z-1650-2009 · posted 2009-07-07 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Risk of misinterpretation of patient response to treatment: Date displayed may be incorrect. Filtering based on examination date may lead to an incorrect list of examinations.
- Action taken
- syngo Imaging has issued a Customer Safety Advisory Notice, dated May 28, 2009, to affected customers via Update Instruction IM019/09/S. The notice informs the customers of the potential issue and provides instructions to avoid its occurrence. A software update to correct this issue is currently being developed and will be installed on affected systems by sygo's service representatives when it becomes available.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 16 units
- Distribution
- Nationwide.
- Date initiated
- 2009-06-01
- Date posted
- 2009-07-07
- Date terminated
- 2013-03-19
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO IMAGING (VERSION V31) (K081734) | Siemens AG Medical Solutions | 2008-07-03 |