—#110712

Product

Siemens syngo.plaza. 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: Model number 10592457

Why it was recalled

Siemens became aware of a potential malfunction when using syngo.plaza with software version VA20C_HF01. For datasets with distance measurements it can happen, that all images are not loaded to Viewer but no error message is displayed to user.

Root cause (FDA determination)

Software design

Action the firm took

Siemens sent a Customer Safety Advisory Notice letter dated February 24, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to ensure that the prefix defined in the viewer settings for "Content Creator's Initials" is not empty. Then all images will be display correctly. This has to be checked for every user. Further questions please call 610-219-6300.

Recalling firm

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

Distribution

Distribution pattern: (USA) nationwide including the states of CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI.

Timeline

Recall initiated: 2012-02-24
Posted by FDA: 2012-07-26
Terminated: 2014-01-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #110712. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.