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 |
|
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 |