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
- ELEKTA SYNERGY PLATFORM
- ELEKTA INFINITY
- PRECISE TREATMENT SYSTEM
- 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