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Clinac, Novalis and Trilogy Linear Accelerators
- Starting date:
- November 28, 2011
- Posting date:
- November 12, 2012
- 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-34581
Recalled products
- Clinac Linear Accelerator
- Clinac IX High Energy Linear Accelerator
- Trilogy High Energy Linear Accelerator
- Novalis TX High Energy Linear Accelerator
- Clinac 2100C High Energy Linear Accelerator
- Clinac 21EX High Energy Linear Accelerator
- Clinac 23EX High Energy Linear Accelerator
Reason
An event occurred with C-series Clinac accelerator. The event entails excessive connector resistance, which caused the actual jaw positions to differ from the intended jaw positions without warning the operator. Normal morning daily quality assurance testing and light field verification detected the discrepancy. Investigation found that a similar issue could arise on the gantry or couch axes. This does not affect the MLC.
Affected products
A. Clinac Linear Accelerator
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 600C
- 600N
- 6EX
Companies
- Manufacturer
-
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto
94304
California
UNITED STATES
B. Clinac IX High Energy Linear Accelerator
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- CLINAC IX
Companies
- Manufacturer
-
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto
94304
California
UNITED STATES
C. Trilogy High Energy Linear Accelerator
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- TRILOGY
Companies
- Manufacturer
-
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto
94304
California
UNITED STATES
D. Novalis TX High Energy Linear Accelerator
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- NOVALIS TX
Companies
- Manufacturer
-
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto
94304
California
UNITED STATES
E. Clinac 2100C High Energy Linear Accelerator
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 2100C
Companies
- Manufacturer
-
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto
94304
California
UNITED STATES
F. Clinac 21EX High Energy Linear Accelerator
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 21EX
Companies
- Manufacturer
-
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto
94304
California
UNITED STATES
G. Clinac 23EX High Energy Linear Accelerator
Lot or serial number
- H290285
Model or catalog number
- 23EX
Companies
- Manufacturer
-
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto
94304
California
UNITED STATES