| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01444-1 |
| Product Name/Description |
iMR Cabinet label of Brilliance iCT, Ingenuity CT, Ingenuity Core 128
Part Number: 459800444981
ARTG Number: 98868 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
8/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
An incorrect current rating label has been applied to the rear side of the IMR (single computer) Host cabinet (4598-004-44981).
The non-conforming label states the current rating as 4.8A (instead of 2.4A), as defined in the Host Rack IMR specifications. The correct label on the host IMR rack should have electrical rating values of: 230V — 2.4A, 50/60 HZ. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips Healthcare is notifying the affected users of those issues via this letter. A Philips Field Service Engineer will contact those users to schedule the Rack/Cabinet label re-work on-site. Reference Field Change Order (FCO) 72800667. This action has been closed-out on 23/06/2017. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |