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.
Reported: July 8, 2015 Initiated: June 11, 2015 #Z-1972-2015
Product Description
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.
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.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 5
- Distribution
- US in the states of NC and NE
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 5.
Why was this product recalled? ▼
During certain clinical workflows safety issues may occur involving monitor assignment order and incorrect display and measurements for images with non square pixel size.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 8, 2015. Severity: Moderate. Recall number: Z-1972-2015.
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