| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00888-1 |
| Product Name/Description |
Integra CT-compatible Intubation Head Ring Assembly (HRAIM), (used to stabilise the head during an imaging procedure) Catalogue Number : HRAIM
All lot numbers
ARTG Number: 160533 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/09/2012 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer identified that when the T-handle on the HRAIM intubation hoop is tightened on some units, it may stop in a vertical position that
prevents the CRWPRECISE (CRW Precision Stereotactic Frame) and CRWASL (CRW Arc System) from being properly seated on the head ring. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Integra is providing work around instructions to mitigate the issue and will be contacting all users to replace affected screws. |
| Contact Information |
1300 550 599 - Integra Customer Service |