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Health product recall

BrightView Imaging Systems (2016-05-25)

Starting date:
May 25, 2016
Posting date:
June 16, 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-58900

Affected products

  1. BRIGHTVIEW XCT IMAGING SYSTEM
  2. SYST, BRIGHTVIEW X WITH CRYSTAL

Reason

During a Non-auto Body Contouring (abc), non-circular, REL-180 scan, the detector may come in contact with the patient. If this occurs, contact sensors would pause the scan.

Affected products

A. BRIGHTVIEW XCT IMAGING SYSTEM

Lot or serial number

Not applicable

Model or catalog number
  • 453560462131
  • 453560749161
Companies
Manufacturer
Philips Medical Systems (Cleveland) Inc.
595 MINER ROAD
CLEVELAND
Ohio
UNITED STATES

B. SYST, BRIGHTVIEW X WITH CRYSTAL

Lot or serial number

Not applicable

Model or catalog number
  • 453560829241
Companies
Manufacturer
Philips Medical Systems (Cleveland) Inc.
595 MINER ROAD
CLEVELAND
Ohio
UNITED STATES