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Health product recall

Elekta Precise Treatment System (2015-01-07)

Starting date:
January 7, 2015
Posting date:
January 28, 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-43483

Recalled products

  1. Elekta Precise Treatment System

Reason

Elekta has identified a batch of securing bolts that fix the gantry counter frame weight stack may fail; the potentially faulty bolts are marked with "OF" on the top. The gantry counter frame weight stack is secured with 6 bolts. The original customer complaint reported that two of the bolts on the machine holding the counter frame sheared within a week of installation.

Affected products

A. Elekta Precise Treatment System

Lot or serial number
  • S/N: 153602
Model or catalog number
  • MRT 6011
Companies
Manufacturer
Elekta Limited
Linac House, Fleming Way
Crowley, Sussex
RH10 9RR
UNITED KINGDOM