Health product recall

AXIOM Artis DBA, DTA, BDC magnetic navigation and Artis zeego multi-axis, zee multi-purpose, zee floor, zee ceiling, zee biplane (2019-06-11)

Starting date:
June 11, 2019
Posting date:
June 28, 2019
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-70323

Last updated: 2019-06-28

Affected Products

  1. AXIOM Artis DBA
  2. AXIOM Artis DTA
  3. AXIOM Artis BDC magnetic navigation
  4. Artis zeego multi-axis
  5. Artis zee multi-purpose
  6. Artis zee floor
  7. Artis zee ceiling
  8. Artis zee biplane

Reason

Siemens is notifying customers of a potential hardware error on Artis zee and AXIOM Artis Systems with a generator A100. A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.

Affected products

A. AXIOM Artis DBA

Lot or serial number

Not applicable.

Model or catalog number

7555357

Companies
Manufacturer
Siemens Healthcare GmbH
Henkestr. 127
Erlangen
91052
GERMANY

B. AXIOM Artis DTA

Lot or serial number

Not applicable.

Model or catalog number

7008605

Companies
Manufacturer
Siemens Healthcare GmbH
Henkestr. 127
Erlangen
91052
GERMANY

C. AXIOM Artis BDC magnetic navigation

Lot or serial number

Not applicable.

Model or catalog number

59 17 054

Companies
Manufacturer
Siemens Healthcare GmbH
Henkestr. 127
Erlangen
91052
GERMANY

D. Artis zeego multi-axis

Lot or serial number

Not applicable.

Model or catalog number

10280959

Companies
Manufacturer
Siemens Healthcare GmbH
Henkestr. 127
Erlangen
91052
GERMANY

E. Artis zee multi-purpose

Lot or serial number

Not applicable.

Model or catalog number

10094139
7555365

Companies
Manufacturer
Siemens Healthcare GmbH
Henkestr. 127
Erlangen
91052
GERMANY

F. Artis zee floor

Lot or serial number

Not applicable.

Model or catalog number

10094135
7412807

Companies
Manufacturer
Siemens Healthcare GmbH
Henkestr. 127
Erlangen
91052
GERMANY

G. Artis zee ceiling

Lot or serial number

Not applicable.

Model or catalog number

10094137

Companies
Manufacturer
Siemens Healthcare GmbH
Henkestr. 127
Erlangen
91052
GERMANY

H. Artis zee biplane

Lot or serial number

Not applicable.

Model or catalog number

10094141
7728392

Companies
Manufacturer
Siemens Healthcare GmbH
Henkestr. 127
Erlangen
91052
GERMANY