Elekta Digital Accelerators

Starting date:
May 28, 2013
Posting date:
August 19, 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-35043

Recalled products

  1. Elekta Precise Treatment System
  2. Synergy Desktop Pro R6.1
  3. Elekta Synergy Platform
  4. Elekta Infinity

Reason

Some digital accelerators have increased electron applicator auto-tracking settings in the field, to values greater than the factory set defaults. Increasing auto-tracking values from factory set defaults can result in the system becoming non-compliant with IEC standards, in particular with the safety standard IEC 60601-2-1.

Affected products

A. Elekta Precise Treatment System

Lot or serial number

All serial numbers 

Model or catalog number
  • MRT 2161
  • MRT 3041
  • MRT 6001
  • MRT 6011
  • XRT 0101
Companies
Manufacturer
Elekta Limited
Linac House, Fleming Way
Crawley, Sussex
RH10 9RR
UNITED KINGDOM

B. Synergy Desktop Pro R6.1

Lot or serial number

All serial numbers

Model or catalog number
  • MRT 10601
Companies
Manufacturer
Elekta Limited
Linac House, Fleming Way
Crawley, Sussex
RH10 9RR
UNITED KINGDOM

C. Elekta Synergy Platform

Lot or serial number

All serial numbers

Model or catalog number
  • XRT 0401
  • XRT 0411
Companies
Manufacturer
Elekta Limited
Linac House, Fleming Way
Crawley, Sussex
RH10 9RR
UNITED KINGDOM

D. Elekta Infinity

Lot or serial number

All serial numbers

Model or catalog number
  • XRT 1501
  • XRT 1511
Companies
Manufacturer
Elekta Limited
Linac House, Fleming Way
Crawley, Sussex
RH10 9RR
UNITED KINGDOM