Health product recall

SYNGO.VIA

Last updated

Summary

Product
SYNGO.VIA
Issue
Medical devices - Lack of efficacy
What to do

Contact the manufacturer if you require additional information

Affected products

Affected Products Lot or serial number Model or catalog number
SYNGO.VIA More than 10 numbers, contact manufacturer 10496180

Issue

After import to Syngo.Via - some items are missing regarding findings(MR prostate) from scanner (Biopsy line; Lesion is shifted; Glandvolume missing) detectability: as the finding positions are also correctly listed in the findings table beneath the prostate graphic, user can detect the discrepancy in the BCR report

Recall start date: 2021-11-10

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-63640