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Consumers and health professionals are advised that Medifab, in consultation with the TGA, is undertaking a recall for product correction for Shuttle Discovery Seats.
The Shuttle Discovery Seat is part of an ergonomic seating system designed for children aged between six months and four years who have a physical disability. The seat can be attached to different bases, for example a stroller, high chair or rocking chair, for different functions.
It has been identified that, when used with a stroller frame that has tie-down fittings for securing the device within a vehicle, there are two issues that can potentially lead to user injury.
On some Shuttle Discovery Seats the rear 'S-tubes' may move in and out excessively when the backrest is rocked backwards and forwards (see image below). Although some movement is normal, there is potential for the 'S-tubes' to come out of the mounting block if the vehicle in which the stroller is being transported is involved in an accident. If this happens, there is the potential for serious injury to the user, although the likelihood of this occurring is very low.
The other issue involves the 'Tilt in Space' plungers not engaging correctly in the plastic sides (see image below). If the vehicle in which the stroller is being transported is involved in an accident and the locking plungers have not engaged correctly, there is potential for the seat tilting back and causing serious injury to the user, although the likelihood of this occurring is very low.
To address these issues, all Shuttle Discovery Seats manufactured before 28 August 2015 need to be upgraded. All such seats should be upgraded, but Medifab is prioritising corrective actions for seats where fittings have been supplied for use in a vehicle with tie-downs.
To date, there have been no reports of injuries as a result of either of these issues.
Information for consumers
All users who have an affected Shuttle Discovery Seat are identifiable through the suppliers of the device.
Medifab, through the suppliers, is contacting those users to provide further information about this issue, including instructions for arranging the upgrades.
The Shuttle Discovery Seat should not be used for transportation in a motor vehicle with tie-downs until the upgrade has occurred. However, if you care for a child who uses one of these devices, due to the likelihood of this problem occurring being very low and the lack of reasonable alternatives, you can continue to use the Shuttle Discovery Seat in other situations.
If you care for a child who uses one of these devices and you have not been contacted, or if you have any questions or concerns about this issue, speak to the supplier of your device or phone Medifab on 1300 543 343.
Information for health professionals
If you are treating a patient who uses a Shuttle Discovery Seat and has a caregiver who has questions or concerns about the above issue, advise them to speak to the supplier of their device or phone Medifab on 1300 543 343.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.