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Health product recall

Various Clinac High Energy Linear Accelerator (2014-06-17)

Starting date:
June 17, 2014
Posting date:
July 15, 2014
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-40511

Recalled products

  1. Clinac iX High Energy Linear Accelerator
  2. Trilogy High Energy Linear Accelerator
  3. Novalis TX High Energy Linear Accelerator
  4. Clinac 2100C/D High Energy Linear Accelerator
  5. Clinac 21EX High Energy Linear Accelerator
  6. Clinac 23EX High Energy Linear Accelerator
  7. Clinac 2300C/D High Energy Linear Accelerator

Reason

Unexpected beam output variations with the C-series high energy linear accelerator for 6mV photon treatment mode.

Affected products

A. 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

B. 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

C. 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

D. Clinac 2100C/D High Energy Linear Accelerator

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • CLINAC 2100C/D
Companies
Manufacturer
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto
94304
California
UNITED STATES

E. Clinac 21EX High Energy Linear Accelerator

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • CLINAC 21EX
Companies
Manufacturer
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto
94304
California
UNITED STATES

F. Clinac 23EX High Energy Linear Accelerator

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • CLINAC 23EX
Companies
Manufacturer
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto
94304
California
UNITED STATES

G. Clinac 2300C/D High Energy Linear Accelerator

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • CLINAC 2300 C/D
Companies
Manufacturer
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto
94304
California
UNITED STATES