| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00605-1 |
| Product Name/Description |
Akron Tilt Table couches
Serial Numbers: P0167499 and P0418644
Model Numbers: A8652 and A8652T
Product Codes: A8652 and A8652T
ARTG Number: 288419
(Arjo Australia Pty Ltd - Table, examination/treatment) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
As part of post market surveillance (complaint reporting) monitoring, ArjoHuntleigh received a complaint related to Akron Tilt Table middle section frame breakage. The investigation showed that one of the critical welds was missing. Not all devices are affected by this defect, however, this issue is seen as a potential hazard and Arjo Australia seeks to prevent the possibility of any related event occurring again.
There was no injury related to this incident. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
ArjoHuntleigh is requesting customers:
Complete and sign the Customer Response Form supplied with the customer letter and return this form to the local ArjoHuntleigh office as per the directions given. An ArjoHuntleigh Service person will contact the person you listed on the Customer Response Form to schedule service to verify and (if needed) rework your device, free of charge.
This action has been closed out on the 11/12/2018. |
| Contact Information |
1800 009 077 - Arjo Australia |