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Health product recall

Mevatron and Oncor Linear Accelerators

Starting date:
May 14, 2013
Posting date:
June 18, 2013
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-34219

Recalled products

  1. Mevatron Linear Accelerators
  2. Oncor Expression
  3. Oncor Impression Plus

Reason

Siemens is issuing control console update version 9.2.18 for digital linear accelerators of type Primus (Primus HI, Mevatron Primus, & Mevatron Primus Plus) and Oncor (Oncor Expression & Oncor Impression Plus) to fix a number of safety issues: cumulative positioning errors, electron or stereotactic treatments with the reticle inserted, delayed error message in ultrafast IMRT treatments, and incorrect verification of the beam shape when using Non-Syngo Primeview.

Affected products

A. Mevatron Linear Accelerators

Lot or serial number
  • 3382
  • 3619
  • 3638
  • 3641
  • 3645
  • 3742
  • 3919
  • 4173
Model or catalog number
  • 4504200
Companies
Manufacturer
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY

B. Oncor Expression

Lot or serial number
  • 5037
  • 5041
  • 5042
  • 5324
Model or catalog number
  • 7360717
Companies
Manufacturer
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY

C. Oncor Impression Plus

Lot or serial number
  • 3799
  • 3865
Model or catalog number
  • 5857912
Companies
Manufacturer
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY