Siemens Syngo Imaging System with VB30A version of software. Model Number: 10014063, Siemans Medical Solutions, Malvern,
FDA device recall Z-0732-2008 · posted 2008-02-23 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Inconsistent data - A buffer overflow may occur between information system and picture system if the system experiences a high load. (e.g. RIS/PACS communication is unusally high)
- Action taken
- The recalling firm issued a Customer Safety Advisory, via certified mail. to the affected customers on 11/27/07. The letter informs the customer of the issue and also provides instruction to detect and avoid its occurrence. In addition, the firm is developing a software update to correct the issue, which will be installed on the affected systems when it is released.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 10 units
- Distribution
- Nationwide Distribution, including states of AL, MO, NC, NY, OH, OR, TN, and TX.
- Date initiated
- 2007-11-27
- Date posted
- 2008-02-23
- Date terminated
- 2008-09-17
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO IMAGING (VERSION V30) (K071114) | Siemens AG Medical Solutions | 2007-05-22 |