FDAClass IIMarch 2, 2016

Syngo Plaza Picture archiving and communication system. recall: Software Issue

Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report, communicate, distribute, store…

Why was Syngo Plaza Picture archiving and communication system. recalled?

Siemens is releasing an updated software version to address several software issues including RGB images will show "?" since calculation of HU is not possible; save as option enabled; changes in access for loading studies; breast region is now properly fitted to segment boundary when clicking fit breast to screen.

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?

Device model numbers: 10863171, 10863172, 10863173

Product
Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report, communicate, distribute, store…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
68
Distribution
Nationwide Distribution including AL CA CT FL IN KS LA MA MD MI MN MO MS NE NY OH OR PA TX WA WI
Recall date
March 2, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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