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Health product recall

Clinac and Trilogy - Linear Accelerator, High Energy Accelerators and Radiotherapy Delivery Systems (2013-10-24)

Starting date:
October 24, 2013
Posting date:
April 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-38989

Recalled Products

A. Clinac Linear Accelerator

B. Trilogy Radiotherapy Delivery System

C. Clinac IX Radio Therapy Delivery System,

D. Clinac IX High Energy Linear Accelerator

E. Trilogy High Energy Linear Accelerator

F. Clinac 2100 C High Energy Linear Accelerator

G. Clinac 21EX High Energy Linear Accelerator

Reason

Incidents of Gantry collisions with patients operating during remote and manual mode motion have been identified.  This action does not pertain to Truebeam devices.

Affected products

A. Clinac Linear Accelerator

Lot or serial number

More than 10 serial numbers, contact manufacturer

Model or catalog number

2100C

21EX

600C

6EX

Companies
Manufacturer

Varian Medical Systems, Inc.

3100 Hansen Way

Palo Alto

94304

California

UNITED STATES



B. Trilogy Radiotherapy Delivery System

 

Lot or serial number

H271159

H271624

H272311

H272421

H291021

H294414

H294798

 

Model or catalog number

TRILOGY

 

Companies
Manufacturer

Varian Medical Systems, Inc.

3100 Hansen Way

Palo Alto

94304

California

UNITED STATES



C. Clinac IX Radio Therapy Delivery System,

 

Lot or serial number

More than 10 serial numbers, contact manufacturer

 

Model or catalog number

CLINAC IX

 

Companies
Manufacturer

Varian Medical Systems, Inc.

3100 Hansen Way

Palo Alto

94304

California

UNITED STATES



D. Clinac IX High Energy Linear Accelerator

 

Lot or serial number

More than 10 serial numbers, contact manufacturer

 

Model or catalog number

CLINAC IX

 

Companies
Manufacturer

Varian Medical Systems, Inc.

3100 Hansen Way

Palo Alto

94304

California

UNITED STATES



E. Trilogy High Energy Linear Accelerator

 

Lot or serial number

H295110

H295141


 

Model or catalog number

TRILOGY

 

Companies
Manufacturer

Varian Medical Systems, Inc.

3100 Hansen Way

Palo Alto

94304

California

UNITED STATES



F. Clinac 2100 C High Energy Linear Accelerator

 

Lot or serial number

H294934


 

Model or catalog number

2100C


 

Companies
Manufacturer

Varian Medical Systems, Inc.

3100 Hansen Way

Palo Alto

94304

California

UNITED STATES



G. Clinac 21EX High Energy Linear Accelerator

Lot or serial number

H140962

H140975

H295099

H295139

Model or catalog number

21EX

Companies
Manufacturer

Varian Medical Systems, Inc.

3100 Hansen Way

Palo Alto

94304

California

UNITED STATES