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Consumers and health professionals are advised that Sunrise Medical, in consultation with the TGA, is undertaking a recall for product correction for Quickie Q7 manual wheelchairs manufactured between 1 September 2009 and 27 November 2013.
It has been identified that over time, and under some usage conditions, the backrest brackets may break and detach from the chair frame. If a backrest bracket breaks and goes unnoticed by the user or care giver, there is a risk that the occupant could fall out of the seat and sustain injury to the head or lower back. The expected failure rate due to this issue is 1.75%. There have been four reported injuries overseas as a result of users unexpectedly falling from the seats. No Australians have been injured.
As part of the recall for product correction Sunrise Medical will replace the brackets on affected wheelchairs with a strengthened version, as used in Quickie Q7 manual wheelchairs manufactured since 27 November 2013, which are not affected by this issue.
The affected products and serial numbers are:
| Product name | Model number | Serial number range | Dates of manufacture |
|---|---|---|---|
| Quickie Q7 manual wheelchair | EIR4 | R4-007239 to R4-022394 | 1 September 2009 to 27 November 2013 |
Information for consumers
If you or someone you provide care for uses a Quickie Q7 manual wheelchair manufactured between 1 September 2009 and 27 November 2013 (see above for affected model and serial numbers), be aware of this recall for product correction.
You will be contacted by the dealer who supplied your device to arrange replacement of affected backrest brackets.
If you have any questions or concerns about this issue, or if you think you have an affected device and are not contacted, talk to your dealer or contact Sunrise Medical by telephone on 02 9678 6600 or email enquiries@sunrisemedical.com.au.
Information for health professionals
If you are treating a patient who uses an affected Quickie Q7 manual wheelchair, please make sure they are aware of this issue.
If they have not been contacted about this recall for product correction, advise them to contact the dealer who supplied their device. If they have any difficulties, they can contact Sunrise Medical by telephone on 02 9678 6600 or email enquiries@sunrisemedical.com.au.
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.