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Health product recall

Oncor Expression Digital Linear Accelerator, Artiste MV-Linear Accelerator, and Oncor Impression IMRT Plus (2014-03-27)

Starting date:
March 27, 2014
Posting date:
April 15, 2014
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-39083

Recalled products

  1. Oncor Expression Digital Linear Accelerator
  2. Artiste MV-Linear Accelerator-Main Unit
  3. Oncor Impression IMRT Plus

Reason

As a result of investigation into complaints related to the treatment table (TXT) that is part of the linear accelerators, the following safety issues were identified:

  1. In very rare instances, the actual table position may significantly deviate from the position at the table side control and the linac control console, but no interlock occurs.  
  2. In sporadic cases the following issue for the table axis lateral, longitudinal and isocentric rotation occurs:
    After a manual table movement with released brake an immediate automatic movement for the same table axis is not possible.

Affected products

A. Oncor Expression Digital Linear Accelerator

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

B. Artiste MV-Linear Accelerator-Main Unit

Lot or serial number
  • 5414
Model or catalog number
  • 8139789
Companies
Manufacturer
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY

C. Oncor Impression IMRT Plus

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