—#107379

Product

Siemens syngo.plaza with software version VA20B_HF04 Product Usage: Radiological image processing system

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K093612
Affected lot / code info: Model number 10592457 - serial numbers 100138, 100263, 100249, 100201, 100198, 100181 and 100146.

Why it was recalled

There is a potential malfunction when using syngo.plaza VA20B_HF04 with USB dongle and archive license. In syngo.plaza VA20B_HF04, there is a scenario where data in Short-Term Storage (STS) could reaming unprotected and not archived. this can happen when an archive server with a USB dongle-based license is enabled with auto archiving. If the disk fill level is reached which triggers auto deleti

Root cause (FDA determination)

Software design

Action the firm took

Siemens sent a Customer Safety Advisory Notice letter dated January 20, 2012 to all affected consignees. The letter identified the affected product, problem, steps to take to avoid this issue, and actions to be taken. Customers were instructed to contact their local Siemens Service to plan for their software update and ensure that this safety advisory is placed in the system's instruction for use.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution (USA) - CA, FL, GA, MO, NY and WA.

Timeline

Recall initiated: 2012-01-20
Posted by FDA: 2012-02-29
Terminated: 2012-09-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107379. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.