Health product recall

Artis Q and Artis Q.Zen (2018-07-30)

Starting date:
July 30, 2018
Posting date:
August 17, 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-67408

Affected products

  1. Artis Q
  2. Artis Q .Zen

Reason

In the affected Artis Systems the temperature of the detector could leave its designed working range (cool down) due to a wrongly configured temperature control unit. This unintentional behavior might occur while the system had been switched off for a longer period of time (e.g. during the night).

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