Health product recall

Somatom Edge Products

Last updated

Summary

Product
Somatom Edge Products
Issue
Medical devices - Quality issue
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected products Lot or serial number Model or catalog number
Somatom Edge Plus Not applicable. 10267000
Somatom Definition Edge System-Ct System Not applicable. 10590000
Somatom Definition As-Main Unit Not applicable. 8098027
Somatom Confidence-System Not applicable. 10590100

Issue

Decreased head image quality on P46 systems after VB20 SP5 installation. This customer advisory notice provides a detailed error and workaround description.

Recall start date: Jan 6, 2022

Additional information

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

Henkestr. 127, Erlangen

Germany, 91052

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63824