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