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Health product recall

BRILLIANCE CT BIG BORE SYSTEM-MAIN UNIT (2016-06-15)

Starting date:
June 15, 2016
Posting date:
June 24, 2016
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-59038

Affected products

A. BRILLIANCE CT BIG BORE SYSTEM-MAIN UNIT

Reason

Philips has become aware that during production, a fastener made of stainless steel may have been used rather than the specified alloy steel. The nonconforming fastener may have been used to manufacture Brilliance CT Big Bore systems.

Affected products

A. BRILLIANCE CT BIG BORE SYSTEM-MAIN UNIT

Lot or serial number

All lots

Model or catalog number

4535 670 88051

Companies
Manufacturer

Philips Medical Systems (Cleveland) Inc.

595 MINER ROAD

CLEVELAND

Ohio

UNITED STATES