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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00500-1
Product Name/Description	Concerto & Basic Shower Trolleys (used for assisted hygiene care) Serial Numbers: 3000846870, 3000852015, 3000856697, 3000856697, 3000856697, 3000646121, 3000674706, 3000674706, 3000676859, 3000674706, 3000717577, 3000717577, 3000720597, 3000720597, 3000756366, 3000766008, 3000783964, 3000783964, 3000783964 Manufactured between 7 March 2014 and 20 April 2015 ARTG Number: 199958
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	28/04/2016
Responsible Entity	Huntleigh Healthcare Pty Ltd
Reason/Issue	As part of post market surveillance (complaint reporting) monitoring, ArjoHuntleigh received a limited number of complaints where the bolts under the stretcher became loose. There has been one minor injury as a result of a patient falling related to these incidents. ArjoHuntleigh investigated the issue and concluded the stretcher mounting bolts or stretcher tilting mechanism can become loose which may make the device unstable, providing a potential for risk to the patient or the caregiver. There is a risk the locking mechanism for the stretcher–tilt function may not engage properly, resulting in a patient falling to the floor.
Recall Action	Recall for Product Correction
Recall Action Instructions	ArjoHuntLeigh is advising users to ensure the trolleys are checked regularly as per the Instructions for Use (IFU). ArjoHuntLeigh will be performing an inspection on all affected devices to ensure the bolts are securely fastened. This action has been closed-out on 16/02/2017.
Contact Information	08 9314 4102 - ArjoHuntleigh