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

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