FDAClass IINovember 29, 2017

Syngo.plaza recall: Software Issue

Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 Syngo.plaza is a Picture Archiving and Communication System (PACS)…

Why was Syngo.plaza 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

non-medical software application Check Tool V1 .0 (L TA Incomplete Archive Check Tool V1 .0)

Product
Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 Syngo.plaza is a Picture Archiving and Communication System (PACS)…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
2 units
Distribution
Distribution to MN
Recall date
November 29, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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