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Apex Mobility is conducting a product correction on the Rifton TRAM and E-Pacer patient transfer and gait training mobility devices. These devices are commonly used to help people with physical disabilities, the elderly, stroke or traumatic brain injury patients. The correction involves replacing the body support system on certain devices that were manufactured before November 2020.
Product details
| Product Name | Model Number | ARTG | Date of Manufacture | ID Code |
|---|---|---|---|---|
| Rifton TRAM | K310 | 340726 | July 2012 to Oct 2020 | K31020120731AA to K31020201009AA |
| Rifton TRAM | K320 | 340726 | Oct 2013 to Nov 2020 | K32020131014AA to K32020201023AB |
| Rifton E-Pacer | K660 | 358470 | Jun 2017 to Apr 2018 and Mar 2019 to Nov 2020 | K66020170712AB to K66020201020AB |
What is the problem?
The TRAM and E-Pacer devices use a body support system that secures the user with straps and buckles. Some metal parts connected to the straps may have sharper edges than intended. Over time, this could cause the strap to wear or fray, which may lead to the strap breaking.
What is the risk?
If a strap breaks, it could lead to a fall from the device and injury. It is possible that if the strap broke during transfer, the injuries could be serious or life threatening.
What should I do?
- You may continue to use the device as normal.
- Monitor the body support system straps for fraying.
- Do not use the device if fraying is visible.
Apex Mobility will supply a replacement body support kit for installation by customers. Once the kit is installed, discard the old body support.
Further information
Please contact Apex Mobility on 1300 212 192 or email sales@apexmobility.com.au for further information.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to our 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.