| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00842-1 |
| Product Name/Description |
Iris Hi Lo Bed
(adjustable electric bed)
Model/Code Number: PHCBED1
ARTG Number: 197050 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
31/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
The TGA has determined that the side rails supplied with this bed do not comply with the below listed standard and that there is a resulting risk of patient harm, including but not limited to patient entrapment:
IEC 60601-2-52:2009: Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
While no safety-related incidents have been reported to date, Pride Australia has, as a precautionary measure have agreed to undertake a Recall for Product Correction. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Pride, requests that users immediately remove the existing side rails in the event they are installed on the bed. To enable you to remove the existing side rails, Pride have supplied a leaflet of instructions demonstrating how to remove the side rails, along with the Customer Letter as an attachment.
Please follow the instructions given to facilitate this recall action.
This action was finalised on 10/09/2018. |
| Contact Information |
03 8770 9600 - Pride Mobility Service Department |