Reported Nov 29, 2017 · Terminated
Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 Syngo.plaza is a Picture Archiving and…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- 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.
- Lot codes and dates
- non-medical software application Check Tool V1 .0 (L TA Incomplete Archive Check Tool V1 .0)
- Amount recalled
- 2 units
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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