| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01225-1 |
| Product Name/Description |
MAQUET operating table accessories with Accessory Adaptor 600525A0
Manufactured from 2002 onwards
ARTG Number: 163023 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/09/2016 |
| Responsible Entity |
|
| Reason/Issue |
The Accessory Adaptor (600525A0) is designed for the mounting of MAQUET accessories with the dovetail guide interface immediately before, during and after surgical interventions as well as for examination and treatment. The Accessory Adapter is used with the Magnus table back plates to attach the horseshoe head rest or the skull clamp. Maquet has been notified of a case where a Head Rest was levered out of the dovetail profile of the Accessory Adaptor. It was identified that the raw material of the Accessory Adaptor did not meet Maquet specifications. While the Accessory Adapter does carry the specified weight of 11kg at a distance of 300mm, the tensile and flexural strength of the material was less than specification.
There is a very rare possibility should the attached accessory release from the Adapter without warning during a surgical procedure that the patient may sustain a cervical spine injury. To date no incident has been reported in which a person was injured. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
MAQUET will be contacting customers to provide a new replacement Accessory Adaptor (600525A0). Until the replacement has been provided, MAQUET is advising users that Accessory Adaptor (600525A0) should not be used.
This action has been closed out on 02/11/2018 |
| Contact Information |
1800 605 824 - Maquet Customer Service |