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Health product recall

RAYSTATION (2015-03-04)

Starting date:
March 4, 2015
Posting date:
April 13, 2015
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-52825

Recalled Products

A. RAYSTATION

Reason

An error was found in DMLC dose calculation for machines where the MLC is positioned above the jaws or the jaws are fixed, e.g. some Elekta Linacs, resulting in an incorrect output factor correction.

Affected products

A. RAYSTATION

Lot or serial number
  • 4.0.1.4
  • 4.0.3.4
Model or catalog number
  • 3.5
  • 4.0
  • 4.5
  • 4.7
Companies
Manufacturer
Raysearch Laboratories AB,
Sveavagen 25,
Stockholm
11134
SWEDEN