—#153715

Product

Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K093612
Affected lot / code info: Device Model Number: 10863171, 10863173 Serial Numbers: 100213 100484 100362 100457 100314 100300 100306 100307 100449 100450 100247 100221 100212

Why it was recalled

Software updates

Root cause (FDA determination)

Software design

Action the firm took

Siemens mailed a notification letter dated February 21, 2017 to affected customers to inform them of the software updates that were now available to address several issues. Customers were advised to follow the instructions in the notice and where necessary promptly notify and instruct all their staff at their organization who have to be aware of the problem. Customers were also instructed to forward the information to new owners where possible. For questions regarding this recall call 610-219-4834.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution to MO,TX, FL, MA, WI, PA, IN, and CA

Timeline

Recall initiated: 2017-02-20
Posted by FDA: 2017-03-10
Terminated: 2017-08-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #153715. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.