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Health product recall

Mevatron, Oncor Expression Digital Linear, Artiste MV Linear Accelerators and Oncor Impression Plus (2014-12-17)

Starting date:
December 17, 2014
Posting date:
January 9, 2015
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-43205

Recalled Products

A) Mevatron Linear Accelerators
B) Oncor Expression Digital Linear Accelerator
C) Artiste MV - Linear Accelerator
D) Oncor Impression Plus

Reason

Siemens has received reports from one electric board (G41) located inside of the linac gantry showing signs of overheating. After a detailed analysis the root cause was found to be one of the components that belong to this board (head driver PCB).

Affected products

A) Mevatron Linear Accelerators

Lot or serial number

2559
3382
3641
3645
3919

Model or catalog number

01940035
04504200

Companies
Manufacturer
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY

B) Oncor Expression Digital Linear Accelerator

Lot or serial number

5037
5041
5324

Model or catalog number

7360717

Companies
Manufacturer
Siemens AG
Wittelsbacherplatz 2
Muenchen, Germany
80333

C) Artiste MV - Linear Accelerator

Lot or serial number

5414

Model or catalog number

8139789

Companies
Manufacturer
Siemens AG
Wittelsbacherplatz 2
Muenchen, Germany
80333

D) Oncor Impression Plus

Lot or serial number

3799

Model or catalog number

5857912

Companies
Manufacturer
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY