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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