Health product recall

BrightView XCT Imaging System and Gamma Camera System

Last updated

Summary

Product
BrightView XCT Imaging System and Gamma Camera System
Issue
Medical devices - Performance issue
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 XCT Imaging System - Tilt System

Not applicable.

453560462131
453560749161

Brightview Gamma Camera System With 3/8" Crystal

Not applicable.

2170-3000A

Brightview Gamma Camera With 3/4" Crystal

Not applicable.

2170-3001A

Brightview Gamma Camera System W/ 3/8" Crystal And Detector Caudal Cephalic Tilt

Not applicable.

2170-3002A

Brightview Gamma Camera System W/ 3/4" Cystal & Detector Caudal Cephalic Tilt

Not applicable.

2170-3003A

Issue

Philips has become aware of a potential safety issue affecting BrightView systems where the detector may unexpectedly fall due to a component failure.

A detector support component may fail due to unexpected wear:

  • Scenario 1: If the detector is below the center of the gantry bore and the detector support component fails, the detector may descend downward unexpectedly and potentially contact the patient.
  • Scenario 2: If the detector is above the center of the gantry bore and the detector support component fails, the detector will not be able to move to complete the imaging.

Philips has received a complaint associated with this issue; however, there are no reports of injury or serious harm.

Recall start date: December 20, 2023

Additional information

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

Philips Medical Systems Nederland B.V.

Veenpluis 6, Best, Netherlands, 5684 PC

Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-74865

Get notified

Receive notifications for new and updated recalls and alerts by category.

Subscribe