Health product recall

ARTIS Q, ARTIS Q. ZEN, and ARTIS PHENO (2018-06-22)

Starting date:
June 22, 2018
Posting date:
July 13, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-67216

Affected products

A. ARTIS Q
B. ARTIS Q. ZEN
C. ARTIS PHENO

Reason

In case of a short-circuit within the x-ray tube a leakage current might cause an overload of the x-ray generator. If this current leakage is undetected it may damage the generator by overheating. X-ray will not be possible.

Affected products

A. ARTIS Q

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

10848280
10848281
10848282
10848283

Companies
Manufacturer
Siemens Healthcare GmbH
Henkestr. 127
Erlangen
91052
GERMANY

B. ARTIS Q. ZEN

Lot or serial number

105012
105102
105103
123048
123214
123217

Model or catalog number

10848353
10848354
10848355

Companies
Manufacturer
Siemens Healthcare GmbH
Henkestr. 127
Erlangen
91052
GERMANY

C. ARTIS PHENO

Lot or serial number

164101

Model or catalog number

10849000

Companies
Manufacturer
Siemens Healthcare GmbH
Henkestr. 127
Erlangen
91052
GERMANY