Health product recall

Artis Q, Icono and Pheno Systems

Last updated

Summary

Product
Artis Q, Icono and Pheno Systems
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Artis Q

More than 10 numbers, contact manufacturer.

10848281
10848283
10848280
10848282

Artis Q.Zen

123214
123506
105103

10848355
10848353

Artis Icono Floor

170369
170382

11327700

Artis Pheno

164123
164367

10849000

Artis Icono Biplane

180441

11327600

Issue

The Artis system is provided with a dedicated error detection mechanism. In rare cases of failure of this error detection mechanism it will not be possible to release x-ray anymore until system shutdown.

Recall start date: August 12, 2022

Additional information

Details
Original published date: 2022-09-23
Alert / recall type
Health product recall
Category
Health product - Medical device - Radiology
Companies

Siemens Healthcare Gmbh

Henkestr. 127, Erlangen, Germany, 91052

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64558