Health product recall

Incisive CT System

Last updated

Summary

Product
Incisive CT 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

Incisive CT System

Not applicable.

728144

Issue

Philips has identified a hardware issue with a metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system. The component's structural integrity may become compromised, resulting in potential contact with other gantry components located within the Incisive CT during rotation. Other components could be damaged due to the contact with the detached component. If this issue occurs, a loud noise will be emitted and the system will shut down. The cover may become displaced if the following sequence occurs:

  • damaged component(s) come loose
  • the damaged component(s) contact other components in the system and cause them to break
  • a broken component makes contact with the top right gantry cover

The displaced cover could create a small gap allowing a fragment of a damaged component to be expelled at a low velocity. The maximum weight of a fragment that could be expelled is 60g (2.12 ounces).

Recall start date: April 18, 2024

Additional information

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

Philips Healthcare (Suzhou) Co., Ltd.

No. 258, Zhong Yuan Road, Suzhou, Jiangsu, China, 215024

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75485

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