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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 Integra Neurosciences Pty Ltd
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