| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00840-1 |
| Product Name/Description |
Aidacare FL250 Bed, Single and King Single
Product Codes: BEB046100 (Single) and BEB046150 (King Single)
Dates of Manufacture – 22 June 2017 to 17 May 2018
ARTG Number: 287924
(Aidacare Pty Ltd - Bed, disabled person, electrical) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
2/07/2018 |
| Responsible Entity |
|
| Reason/Issue |
Aidacare has identified a labelling error pertaining to Electrical Classification on the Manufacturer ID Sticker – it is shown as Class II device when the device is Class I. This mislabelling creates the potential for testing and tagging to be incorrectly administered on FL250 beds.
The class is labelled correctly on the control unit under the bed. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Aidacare is advising that they will contact impacted customers to arrange for on-site correction.
This action has been closed out on 17/04/2020 |
| Contact Information |
1300 133 120 - Aidacare |