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Health product recall

Integrity R1.2-MK3i, R1.2-MK4, and R3.2 (2017-11-03)

Starting date:
November 3, 2017
Posting date:
November 22, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
Healthcare Professionals, General Public, Hospitals
Identification number:
RA-65202

Affected products

A. INTEGRITY R1.2 - MK 3I

B. INTEGRITY R1.2 - MK 4

C. INTEGRITY R3.2

Reason

Elekta have identified that it is possible to get positional error with the precise treatment table following automatic table movement. This can occur if there is an undetected failure of the positional sensors.

Affected products

A. INTEGRITY R1.2 - MK 3I

 

Lot or serial number

INTEGRITY R1.2

Model or catalog number

MRT 1504976

Companies
Manufacturer

Elekta Limited

Linac House, Fleming Way

Crowley, Sussex

RH10 9RR

UNITED KINGDOM



B. INTEGRITY R1.2 - MK 4

Lot or serial number

INTEGRITY R1.2

Model or catalog number

MRT 1504984

Companies
Manufacturer

Elekta Limited

Linac House, Fleming Way

Crowley, Sussex

RH10 9RR

UNITED KINGDOM



C. INTEGRITY R3.2

Lot or serial number

INTEGRITY R3.2

Model or catalog number

MRT 23551

Companies
Manufacturer

Elekta Limited

Linac House, Fleming Way

Crowley, Sussex

RH10 9RR

UNITED KINGDOM