Health product recall

SOMATOM Definition Edge

Last updated

Summary

Product
SOMATOM Definition Edge
Issue
Medical devices - Software defect
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products Lot or serial number Model or catalog number
SOMATOM DEFINITION AS - MAIN UNIT ALL WITH INITIAL RELEASE VB20 8098027
SOMATOM DEFINITION FLASH SYS - MAIN ALL WITH INITIAL RELEASE VB20 10430603
SOMATOM DEFINITION EDGE SYSTEM - CT SYSTEM ALL WITH INITIAL RELEASE VB20 10590000
SOMATOM FORCE ALL WITH INITIAL RELEASE VB20 10742326
SOMATOM DRIVE ALL WITH INITIAL RELEASE VB20 10431700
SOMATOM CONFIDENCE - SYSTEM ALL WITH INITIAL RELEASE VB20 10590100
SOMATOM EDGE PLUS ALL WITH INITIAL RELEASE VB20 10267000

Issue

Sporadic problems with the current software may result in workflow interruptions. (With software versions Syngo.CT VB20 or VB20 SP1 or VB20 SP2 or VB20 SP3 or VB20 SP4.)

 

Recall start date: 2021-11-08

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies

SIEMENS HEALTHCARE LIMITED

1577 NORTH SERVICE ROAD EAST

OAKVILLE, ON CANADA
L6H 0H6

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63637

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