| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00984-1 |
| Product Name/Description |
Maquet Operating Table with Fixture 1002.65AO
Manufactured in the period between 2009 and 2013
ARTG Number: 163023 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
22/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
The fixture (1002.65AO) is designed as a connecting element for the support and positioning of the patient’s head on a Maquet Operating Table immediately before, during and after surgical interventions and as for examination and treatment. The fixture is used to adapt a range of different head rest and horseshoe head rests with a central square mount.
Post market surveillance reported that the welded joint between the square mount and the first fixable swivel joint had broken. As a cantilever design, this joint must bear the highest load of all welded joints. It has been determined that the breakage had been caused by ineffective welding in addition to rough handling and multiple overloading. Serious injury to the patient's cervical spine may occur if the weld seam breaks during a procedure. There have been no reports of injuries as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A Maquet service technician will be contacting customers to arrange an appointment to carry out replacement of all associated components. Until the replacement has been performed, users are advised that the device should be inspected for damage before every use. In this context, particular attention should be paid to the potential for cracks at the weld in the area illustrated in the customer letter. In case of doubt, customers are advised not to use the fixture. This action has been closed-out on 26/05/2017. |
| Contact Information |
1800 605 824 - Maquet Australia Customer Service |