—#111341

Product

syngo.plaza, Model number 10592457. Intended use: radiological image processing system.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K101666
Affected lot / code info: Serial Numbers: 100263, 100401, 100177, 100138, 100174, 100219, 100406, 100249, 200040, 100201, 100198, 100181, 100301, & 100146.

Why it was recalled

There is a potential malfunction in which a miscalculation occurs for images with pixel depth values greater that 12 bit in certain functions.

Root cause (FDA determination)

Software design

Action the firm took

The firm initiated their recall/correction of this device on July 18, 2012 by sending a "Customer Safety Advisory Notice" letter, dated July 12, 2012, to their consignees. The letter identified the affected product along with the malfunction. It also discussed the steps the user can take to avoid the issue. Users were asked to not use the mentioned functions for images from those modalities until the issue was resolved and the system was updated with the software version containing the solution. Users were to contact their local Siemens Service in order to plan for the updated software version that will resolve the issue. Additionally, users should place the safety advisory notice in the system's instructions for use, and personnel should be instructed accordingly and maintain awareness. If the device was sold and is no longer in the users' possession, the notice should be forwarded to the new owner and the firm should be notified of the new owner.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution -- CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI.

Timeline

Recall initiated: 2012-07-18
Posted by FDA: 2012-08-27
Terminated: 2014-01-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #111341. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.