Health product recall

Precedence System - 6 and 16 Slice, Brightview Gamma - Camera Sy. W/ 3/8" Crystal & Detector Caudal Cephalic Tilt, Xct Imaging System - Tilt System and Syst, Brightview X With Crystal, 3/8" (Upgradeable Version) (2017-12-21)

Starting date:
December 21, 2017
Posting date:
January 8, 2018
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-65602

Affected Products

A. PRECEDENCE SYSTEM - 16 SLICE
B. PRECEDENCE SYSTEM - 6 SLICE
C. BRIGHTVIEW GAMMA CAMERA SY. W/ 3/8" CRYSTAL & DETECTOR CAUDAL CEPHALIC TILT
D. BRIGHTVIEW XCT IMAGING SYSTEM - TILT SYSTEM
E. SYST, BRIGHTVIEW X WITH CRYSTAL, 3/8" (UPGRADEABLE VERSION)

Reason

Philips has identified an issue during collimator exchange that may result in the collimator falling from the detector head or collimator cart.

Affected products

A. PRECEDENCE SYSTEM - 16 SLICE

Lot or serial number

Not applicable

Model or catalog number

2169-3000A

Companies
Manufacturer
Philips Medical Systems (Cleveland) Inc.
595 Miner Road
Cleveland
44143
Ohio
UNITED STATES

B. PRECEDENCE SYSTEM - 6 SLICE

Lot or serial number

Not applicable

Model or catalog number

2169-3003A

Companies
Manufacturer
Philips Medical Systems (Cleveland) Inc.
595 Miner Road
Cleveland
44143
Ohio
UNITED STATES

C. BRIGHTVIEW GAMMA CAMERA SY. W/ 3/8" CRYSTAL & DETECTOR CAUDAL CEPHALIC TILT

Lot or serial number

Not applicable

Model or catalog number

2170-3002A

Companies
Manufacturer
Philips Medical Systems (Cleveland) Inc.
595 Miner Road
Cleveland
44143
Ohio
UNITED STATES

D. BRIGHTVIEW XCT IMAGING SYSTEM - TILT SYSTEM

Lot or serial number

Not applicable

Model or catalog number

453560462131

Companies
Manufacturer
Philips Medical Systems (Cleveland) Inc.
595 Miner Road
Cleveland
44143
Ohio
UNITED STATES

E. SYST, BRIGHTVIEW X WITH CRYSTAL, 3/8" (UPGRADEABLE VERSION)

Lot or serial number

Not applicable

Model or catalog number

453560829241
 

Companies
Manufacturer
Philips Medical Systems (Cleveland) Inc.
595 Miner Road
Cleveland
44143
Ohio
UNITED STATES