—#67179

Product

Siemens Syngo Imaging System with VB30A version of software. Model Number: 10014063, Siemans Medical Solutions, Malvern, PA 19355

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K071114
Affected lot / code info: Serial Numbers: 1005, 1065, 1076, 1112, 1202, 1242, 1269, 1278, 1279, and 1282.

Why it was recalled

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)

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern: Nationwide Distribution, including states of AL, MO, NC, NY, OH, OR, TN, and TX.

Timeline

Recall initiated: 2007-11-27
Posted by FDA: 2008-02-23
Terminated: 2008-09-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #67179. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.