—#142876

Product

Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Stores and archives within DICOM structured reports. Integrates hospital/radiology information systems.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K093612, K132532
Affected lot / code info: Device model numbers: 10863171, 10863172, 10863173

Why it was recalled

Siemens is releasing an updated software version to address several software issues including RGB images will show "?" since calculation of HU is not possible; save as option enabled; changes in access for loading studies; breast region is now properly fitted to segment boundary when clicking fit breast to screen.

Root cause (FDA determination)

Software design

Action the firm took

Siemens sent a Voluntary Correction and Removal Action letter dated December 30, 2015. The letter identified the product, the problem, and the action to be taken by the customer. Customers were notified that a software update VB10A_HF01/06 is being released simulataneously to eliminate the issue. Customers with questions were instructed to call 1-888-826-9702.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: Nationwide Distribution including AL CA CT FL IN KS LA MA MD MI MN MO MS NE NY OH OR PA TX WA WI

Timeline

Recall initiated: 2015-12-22
Posted by FDA: 2016-02-23
Terminated: 2017-09-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #142876. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.