This page has been archived on the Web

Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.

Health product recall

4D Integrated Treatment Console (2014-08-18)

Starting date:
August 18, 2014
Posting date:
September 11, 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-41343

Recalled Products

4D Integrated Treatment Console

Reason

Unexpected auxiliary device authorization - two successive ready signals from Exac Trac to 4D Integrated Treatment Console (4DITC) through auxiliary device interface, will unexpectedly clear both Exac Trac interlock and the Barcode Conical Collimator Verification (BCCV) interlock on the linac.

Affected products

4D Integrated Treatment Console

Lot or serial number

4DITC version 10
4DITC version 11

Model or catalog number

V8.8

Companies
Manufacturer
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto
94304
California
UNITED STATES