Health product recall

Artis Pheno System

Last updated

Summary

Product
Artis Pheno System
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
Artis Pheno System 164123 164101 164221 164367 10849000

Issue

The Artis Pheno System is provided with a dedicated error management mechanism. In rare cases of specific X-ray tube failures, the system is intended to automatically switch over to "bypass fluoroscopy" mode. However, in case such a failure occurs while the "block radiation" functionality is active, the "block radiation" functionality cannot be unlocked, and the system will not switch over to "bypass fluoroscopy" mode. In "bypass fluoroscopy" mode a limited imaging functionality (nonsubtracted, Continuous fluoroscopy with reduced power and without acquisition and storage of images) would remain available.

Recall start date: September 23, 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
Healthcare
Industry
Recall class
Type II
Identification number
RA-64587