| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00400-1 |
| Product Name/Description |
ROHO High Profile and Mid Profile Single Compartment Cushion with Sensor Ready Technology
Multiple Model Numbers
Serial Numbers between A2920163 and A3185287
Production dates from 8 January 2016 to 28 February 2017
ARTG Number: 111106 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/04/2017 |
| Responsible Entity |
|
| Reason/Issue |
A problem was discovered internally with a supplied component for the affected products listed above. When a Smart Check by ROHO (Smart Check), model number SMARTCHECK-01, is used to perform a Smart Setup with one of the affected cushions, the nonconforming part may adversely affect the setup process resulting in an improper cushion setup. Sitting on an over inflated or under inflated Sensor Ready Cushion may reduce or eliminate the benefits provided by the cushion, increasing the risk to skin or to other soft tissue.
(Please note that this risk is not present when the Sensor Ready Cushion is used without the Smart Check nor is the risk present when the Sensor Ready Cushion is used with the Smart Check and the setup is performed using the Optional Setup mode). |
| Recall Action |
Recall |
| Recall Action Instructions |
Permobil is advising users to return affected stock to their distributor. Distributors are requested to then contact Permobil to organise a replacement of the affected stock.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1300 845 483 - Permobil |