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Health product recall

Brightview XCT Imaging System

Starting date:
December 28, 2016
Posting date:
January 25, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-61948

Reason

The intended use statement listed in the instructions for use (IFU) for Brightview XCT Systems is stated incorrectly.

Affected products

Brightview XCT Imaging System

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

  • 453560825881

Companies

Manufacturer
Philips Medical Systems (Cleveland) Inc.
595 MINER ROAD
CLEVELAND
44143
Ohio
UNITED STATES