TrueBeam, TrueBeam STx, and TrueBeam Edge (2018-08-22)
- Starting date:
- August 22, 2018
- Posting date:
- September 7, 2018
- 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-67694
Affected products
- TrueBeam
- TrueBeam STx
- TrueBeam Edge
Reason
Unintended override of gated treatment plan.
Affected products
A. TrueBeam
Lot or serial number
- Serial #: H191075
- Serial #: H191332
- Serial #: H191333
- Serial #: H191417
- Serial #: H191491
- Serial #: H191650
- Serial #: H191652
- Serial #: H191676
- Serial #: H192169
- Serial #: H192703
Model or catalog number
- Versions 2.0
- Versions 2.5
Companies
- Manufacturer
-
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto
94304
California
UNITED STATES
B. TrueBeam STx
Lot or serial number
- Serial #: H191038
- Serial #: H191318
- Serial #: H191321
Model or catalog number
- Versions 2.0
- Versions 2.5
Companies
- Manufacturer
-
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto
94304
California
UNITED STATES
C. TrueBeam Edge
Lot or serial number
Serial #: H192301
Model or catalog number
- Versions 2.0
- Versions 2.5
Companies
- Manufacturer
-
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto
94304
California
UNITED STATES