Health product recall

All Elekta Limited Digital Accelerators (2021-09-17)

Starting date:
September 17, 2021
Posting date:
October 8, 2021
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-76599



Last updated:
2021-10-08

Affected Products

  1. ELEKTA SYNERGY PLATFORM
  2. ELEKTA INFINITY
  3. PRECISE TREATMENT SYSTEM
  4. VERSA HD

Reason

There is a risk that the diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter. As the destructive event results in the release of silicon oil and ceramic fragments, further mitigating actions need to be taken when dealing with the diode failure, to reduce the risk of injury to users in the immediate vicinity.

Affected products

A.  ELEKTA SYNERGY PLATFORM

Lot or serial number

Not applicable

Model or catalog number
  • XRT 1402
  • XRT 1412
Companies
Manufacturer

Elekta Limited

Fleming Way

Linac House

RH10 9RR

UNITED KINGDOM


B.  ELEKTA INFINITY

Lot or serial number

Not applicable

Model or catalog number
  • XRT 1501
  • XRT 1511
Companies
Manufacturer

Elekta Limited

Fleming Way

Linac House

RH10 9RR

UNITED KINGDOM


C.  PRECISE TREATMENT SYSTEM

Lot or serial number

Not applicable.

Model or catalog number
  • XRT 1083
  • XRT 1093
Companies
Manufacturer

Elekta Limited

Fleming Way

Linac House

RH10 9RR

UNITED KINGDOM


D.  VERSA HD

Lot or serial number

Not applicable.

Model or catalog number
  • XRT 20319
  • XRT 20419
Companies
Manufacturer

Elekta Limited

Fleming Way

Linac House

RH10 9RR

UNITED KINGDOM