Medical device manufacturer, ArjoHuntleigh, has issued a medical device safety alert concerning its Akron Tilt Table [Model Number: A8652, A8652T; Serial Number: Between P0167499 and P0418644].
The manufacturer received a customer complaint related with Akron Tilt Table middle section frame breakage in its post-market surveillance monitoring. The investigation showed that one of critical welds in the part was missing. There was no injury related to this incident.
According to the manufacturer, the issue is related with potential hazard for patients and if the affected device will be used it can lead to collapse during movement to the vertical position. In the worst case, scenario user can fall down with the upholstery (if not protected with belts).
The manufacturer will arrange a service technician to visit the facilities to carry out welds presence verification and the frame replacement if a missing weld/missing welds would be detected. It is not recommended to use the couch until action would be taken by the manufacturer.
The affected customers are instructed to ensure that all caregivers and users of the affected devices are made aware of the Field Safety Notice and all listed devices at their facilities are available to be corrected during service technician visit.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 23 May 2018