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Health product recall

All Elekta Limited Digital Accelerators with XVI or iViewGT (2017-12-06)

Starting date:
December 6, 2017
Posting date:
December 8, 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-65360

Affected products

A. ELEKTA SYNERGY PLATFORM
B. ELEKTA INFINITY
C. PRECISE TREATMENT SYSTEM
D. ELEKTA AXESSE
E. VERSA HD

Reason

Elekta has identified that if the microswitch within the PCB assembly, solenoid limit switch, of the middle arm is incorrectly setup, there is a potential for an uncontrolled extention of iViewGT / XVI detector arms.

Affected products

A. ELEKTA SYNERGY PLATFORM

Lot or serial number

Not Applicable

Model or catalog number

XRT 1402
XRT 1412

Companies
Manufacturer
Elekta Limited
Linac House, Fleming Way
Crowley, Sussex
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
Linac House, Fleming Way
Crowley, Sussex
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
Linac House, Fleming Way
Crowley, Sussex
RH10 9RR
UNITED KINGDOM

D. ELEKTA AXESSE

Lot or serial number

Not Applicable

Model or catalog number

XRT 20119
XRT 20219

Companies
Manufacturer
Elekta Limited
Linac House, Fleming Way
Crowley, Sussex
RH10 9RR
UNITED KINGDOM

E. VERSA HD

Lot or serial number

Not Applicable

Model or catalog number

XRT 20319
XRT 20419

Companies
Manufacturer
Elekta Limited
Linac House, Fleming Way
Crowley, Sussex
RH10 9RR
UNITED KINGDOM