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Siemens Medical Solutions USA, Inc recalls Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 Syngo.plaza is a Picture Archiving a
Recalled November 29, 2017 · FDA recall Z-0168-2018 · Siemens Medical Solutions USA
Hazard
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. · FDA Class II
Units
2 units
Sold at
Distribution to MN
Description
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.
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.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →