Health product recall

Mammomat Revelation

Last updated

Summary

Product
Mammomat Revelation
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected products Lot or serial number Model or catalog number
Mammomat Revelation More than 10 numbers, contact manufacturer. 11343300

Issue

The new software version VC20G provides latest cybersecurity updates and improvements in the following categories:
- Improves overall system stability
- Improves dicom connectivity
- Improves biopsy workflow

Specifically, the new software version updates some d icom tags related to pre-fix for spot images and spatial locations preserved. It eliminates lock conflict during tomosynthesis reconstruction and detector connection issues. Updated user messages provide clear guidance during the biopsy procedure.

Recall start date: May 2, 2023

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
Healthcare
Industry
Recall class
Type II
Identification number
RA-73643