—#156080

Product

Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 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 work flows. 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: non-medical software application Check Tool V1 .0 (L TA Incomplete Archive Check Tool V1 .0)

Why it was recalled

Siemens is releasing a non-medical software application LTA Incomplete Archive Check Tool V1.0. It is intended to eliminate an issue that occurs during syngo.plaza de-archiving from Dicom LTA. It has been defined that the number of de-archived images is less than the count of the archived images for the series. The issues were discovered through Siemens Global Complaint Handling System.

Root cause (FDA determination)

Software design

Action the firm took

Siemens sent an Customer Information Letter dated May 17, 2017. Customers Instructions: If the device has been sold and therefore no longer in your possession, please forward this notice to the new owner. We would also request that you inform us of the identity of the device's new owner where possible. Please observe this safety notice and comply with the corresponding measure until the update has been fully completed. For further questions, please call (610) 448-6478.

Recalling firm

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

Distribution

Distribution pattern: Distribution to MN

Timeline

Recall initiated: 2017-05-22
Terminated: 2018-07-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #156080. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.