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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00261-1
Product Name/Description Philips Ingenuity CT system

Model Number: 728326

Serial Number: 336182

ARTG Number: 98868
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 24/02/2017
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue It has been identified that the couch rear subframe cover may not be strong enough in the area around the Philips logo lettering to prevent cracking during normal operations. If the cover is impacted by excessive force as a result of contact with medical transportation equipment or accessories, the cover may crack, creating a potential for injury.
Recall Action Recall for Product Correction
Recall Action Instructions Philips is advising users to observe the cautions included in their system user documentation and retain the recall notification with the Instructions For Use (IFU). Users are further advised to contact Philips if there are indications that their system is not operating properly.
This action has been closed-out on 01/03/2018.
Contact Information 1800 251 400 - Philips Customer Care Centre