Health product recall

Brightview System

Last updated

Summary

Product
Brightview System
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Brightview Gamma Camera Sy. W/ 3/4" Crystal & Detector Caudal And Cephalic Tilt

Not applicable.

2170-3003A

Brightview Gamma Camera Sy. W/ 3/8" Crystal & Detector Caudal Cephalic Tilt

Not applicable.

2170-3002A

Brightview Gamma Camera System With 3/8" Crystal

Not applicable.

2170-3000A

Brightview Gamma Camera System With 3/4" Crystal

Not applicable.

2170-3001A

Issue

Philips has become aware of a potential safety issue affecting Brightview systems that may present an extremity entrapment hazard to patients during a scan. While using pre-programmed motion (PPM) during an extrinsic quality assurance scan, a gap is created between the patient support and the detector. This gap presents a potential extremity entrapment hazard for patients while the system detectors and patient support are in motion.

Recall Start Date: December 8, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies

Philips Medical Systems Nederland B.V.

Veenpluis 6, Best, Netherlands, 5684 PC

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74793

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