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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-01083-1
Product Name/Description ORT100 Neurosurgical Table (for Intra-operative MRI Suites)

Serial Numbers: 10002343 & 10003241

Part Number: 110470-000

ARTG Number: 136622
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 23/10/2012
Responsible Entity Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Reason/Issue Emergo Group has recently discovered that when proper procedure is not followed that the foot end of the IMRIS intra-operative OR table may be attracted to the MRI magnet as the magnet approaches the table. This poses a potential risk of injury to both the patient and operators standing near the table.
Recall Action Recall for Product Correction
Recall Action Instructions Emergo is updating the Instructions for Use (IFU) and MR Conditional Labels on the affected tables.
Contact Information 0432 213 360 - Michael Thomas