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[Recalled] Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers: 10863171, 10863172, 10863173 Syngo.plaza is a Picture Archiving and Communication System (PACS) software device intended

recall fda device united-states

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

ProductSyngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers: 10863171, 10863172, 10863173 Syngo.plaza is a Picture Archiving and Communication System (PACS) software device intended to display, process, read, report, communicate, distribute, store and
Brand / manufacturerSiemens Medical Solutions USA, Inc
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0495-2018
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date18 August 2017
EAN / barcode10863171

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Software update to correct several issues that include (1)Potential data loss, (2) Study mix-up, (3) Incorrect measurements on multi-frame images, (4) Dearchiving issue, and (5) Unauthorized access of data due to inadequate permissions for shared folders.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Siemens Medical Solutions USA, Inc

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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