Health product recall

BrightView XCT Imaging System and Gamma Camera System (2019-06-02)

Starting date:
June 2, 2019
Posting date:
June 28, 2019
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-70311



Last updated: 2019-06-28

Affected Products

  1. BrightView XCT Imaging System
  2. BrightView Gamma Camera System
  3. BrightView Gamma Camera System

Reason

An issue has been found with the handcontroller for the brightview family of cameras that has been found to result in either spontaneous uncommanded motions or continued motion after the buttons were released. Philips continues to investigate the issue.

Affected products

A. BrightView XCT Imaging System

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

4.5356E+11

Companies
Manufacturer

Philips Medical Systems Nederland B.V.

Veenpluis 4-6

Best

5684 PC

NETHERLANDS


B. BrightView Gamma Camera System

Lot or serial number

All lots.

Model or catalog number

4.53561E+11

Companies
Manufacturer

Philips Medical Systems Nederland B.V.

Veenpluis 4-6

Best

5684 PC

NETHERLANDS


C. BrightView Gamma Camera System

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

4.53561E+11

Companies
Manufacturer

Philips Medical Systems Nederland B.V.

Veenpluis 4-6

Best

5684 PC

NETHERLANDS