Health product recall

Philips Incisive CT

Last updated

Summary

Product
Philips Incisive CT
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

Incisive Ct

All lots.

728143

Issue

Philips has identified a hardware issue with a metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the incisive CT system. This component may become detached and make contact with other 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: May 1, 2023

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-73644

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