—#138013

Product

SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K071114, K081734
Affected lot / code info: model number: 10014064 serial numbers: 5846 5847 4333 4334 4335

Why it was recalled

During certain clinical workflows safety issues may occur involving monitor assignment order and incorrect display and measurements for images with non square pixel size.

Root cause (FDA determination)

Software design

Action the firm took

Siemens sent a Customer Advisory Notice, dated June 11, 2015, to their customers. The letter identified the affected product, problem and actions to be taken. Customers were also asked to check the software version and consider whether the issue impacts clinical routine and if a software update is necessary.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern: US in the states of NC and NE

Timeline

Recall initiated: 2015-06-11
Posted by FDA: 2015-07-02
Terminated: 2017-03-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #138013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.