—#134102

Product

Syngo.plaza. 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.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K093612, K132532, K955394
Affected lot / code info: Model Numbers of device: 10592457, 10863172, serial numbers: 100177 100033 100181 100029

Why it was recalled

Possibly incomplete archived studies during pre-fetch. In a server farm setup, when pre-fetch/retrieve operation is performed for partially archived studies, the series that have not yet been archived, will remain unarchived.

Root cause (FDA determination)

Software design

Action the firm took

Safety Advisory Notice, dated February 18, 2015, was sent to end users that identified the product, problem, and action to be taken. Users were advised not to manually remove the delete protection in the STS.

Recalling firm

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

Distribution

Distribution pattern: US Distribution: MA, WI, FL

Timeline

Recall initiated: 2015-02-18
Posted by FDA: 2015-03-30
Terminated: 2016-08-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #134102. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.