Product Wiki · Recalls · U.S. FDA — Device Enforcement

SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture… — recall Z-1972-2015

U.S. FDA — Device Enforcement · United States · 2015-06-11 · Class II

As described by U.S. FDA — Device Enforcement: 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.

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1972-2015
Date of alert
2015-06-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Medical Solutions USA, Inc
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
US in the states of NC and NE
Reported risk: During certain clinical workflows safety issues may occur involving monitor assignment order and incorrect display and measurements for images with non square pixel size.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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