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Health product recall

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

  1. Clinac Linear Accelerator
  2. Clinac IX High Energy Linear Accelerator
  3. Trilogy High Energy Linear Accelerator
  4. Novalis TX High Energy Linear Accelerator
  5. Clinac 2100C High Energy Linear Accelerator
  6. Clinac 21EX High Energy Linear Accelerator
  7. 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