—#163217

Product

Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 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: K132532
Affected lot / code info: All Serial Numbers

Why it was recalled

Software upgrade to correct format of study dates and issues with Legacy Presentation States (annotations) in order to prevent potential patient misdiagnosis.

Root cause (FDA determination)

Software design

Action the firm took

On February 25, 2018 a Customer Information Letter was mailed to customers. This notification informed customers of the software changes related to All Sygno.plaza systems with VB20A. Customers were asked to install an updated software patch and instructed to share the notification with all users of the affected product. Customers with questions should call Siemens Customer Care Centre at (866)823-9702. For further questions, please call (610) 448-6461.

Recalling firm

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

Distribution

Distribution pattern: USA (nationwide)

Timeline

Recall initiated: 2018-02-20
Terminated: 2019-07-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #163217. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.