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Terminated

SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.

FDA Recall Z-1972-2015 · Posted 2015-07-02

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2015-06-11
Date Terminated2017-03-24
Product Quantity5

Reason for Recall

During certain clinical workflows safety issues may occur involving monitor assignment order and incorrect display and measurements for images with non square pixel size.

Firm Action

Siemens sent a Customer Advisory Notice, dated June 11, 2015, to their customers. The letter identified the affected product, problem and actions to be taken. Customers were also asked to check the software version and consider whether the issue impacts clinical routine and if a software update is necessary.

Root Cause

Software design

Distribution Pattern

US in the states of NC and NE

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081734SYNGO IMAGING (VERSION V31)Siemens AG Medical Solutions · 2008-07-03K071114SYNGO IMAGING (VERSION V30)Siemens AG Medical Solutions · 2007-05-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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