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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 Aidacare Pty Ltd
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