Elekta Digital Accelerators (May 28, 2013)

Starting date:
May 28, 2013
Posting date:
May 28, 2013
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-35043

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
Not Applicable



B. Synergy Desktop Pro R6.1

Lot or serial number

All serial numbers

Model or catalog number

MRT 10601

Companies

Manufacturer
Not Applicable



C. Elekta Synergy Platform

Lot or serial number

All serial numbers

Model or catalog number

XRT 0401, XRT 0411

Companies

Manufacturer
Not Applicable



D. Elekta Infinity

Lot or serial number

All serial numbers

Model or catalog number

XRT 1501, XRT 1511

Companies

Manufacturer
Not Applicable