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 |
|
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 |