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Rehab Assist C-Series ceiling hoists
Recall for product correction - potential for attachment swivel to break
Consumers and health professionals are advised that Rehab Assist, in consultation with the TGA, is undertaking a recall for product correction of some carry bars used with its C-Series ceiling hoists due to the potential for a plastic attachment swivel to break.
Ceiling hoists are used to help lift and move people who have limited mobility, for example from a bed to a chair. They involve a track attached to the ceiling from which a carry bar is suspended. The person being moved is carried in a sling hung from the carry bar.
Some C-Series carry bars are attached to the track using a plastic swivel. If the plastic swivel in these bars becomes damaged there is the potential for it to separate from the carry bar, resulting in a patient fall. As part of this recall for product correction Rehab Assist will supply a free metal insert to be placed inside affected carry bars to prevent separation if the plastic swivel becomes damaged.
There have been nine incidents worldwide in which the plastic swivel mechanism has been reported as damaged. No incidents have been reported in Australia and there have been no injuries reported as a result of this issue.
A 'puck' with a damaged plastic swivel. Look for any form of crack or divot or unusual widening of the opening.
Affected C-Series carry bars have the following model numbers:
- 360755 Rev B
The affected bars have been supplied with the following ceiling hoist models:
- C300 Manual Traverse (model number 330050)
- C450 Manual Traverse (323100)
- C450 RTC Power Traverse (323149)
- C450 Manual Traverse Rev A (323211)
- C450 Manual Traverse Rev G (323251)
- C450 Power Traverse Rev B (323225)
- C450 Power Traverse Rev B Wide (323223)
- C450 XY (6-way) (323177)
- C625 Manual Traverse (323117)
- C625 Manual Traverse (323118)
- C625 Power Traverse (323126)
Please note that models supplied with a carry bar using a metal swivel in the 'puck' are not subject to this recall action.
Information for consumers
If you or someone you provide care for uses a Rehab Assist C-Series ceiling hoist, be alert to this issue.
Check the serial numbers on the ceiling hoist mechanism and carry bar. If they match one of the affected models listed above, Rehab Assist will supply a free metal insert to be placed inside all affected carry bars to prevent separation.
Users are advised to inspect the swivel for damage or contact your distributor to arrange for a technician to do an inspection. Look for any crack or divot or unusual widening of the opening. If there is no damage the lift can continue to be used as normal. The metal insert should be installed as soon as practicable.
If the swivel appears damaged, do not use the lift until the metal insert has been inserted. Wherever the plastic swivel is damaged, users are also advised to purchase and replace the carry bar as soon as possible.
Rehab Assist advises that the installation of the insert is simple and does not require a technician, although if a technician is available they should undertake this task.
Contact Rehab Assist on 1300 364 534 or 03 9729 7978 for further information and instructions on obtaining and installing the metal insert and the type of damage to look for.
Please note, installation of the metal insert will limit the range of the swivel to 30°. If you require a swivel range greater than 30°, advise Rehab Assist and they will work to find an acceptable solution for your needs.
Information for health professionals
If you are treating a patient who uses a Rehab Assist C-Series ceiling hoist, alert them to this issue. Advise them to check the swivel or arrange for a technician to inspect it.
Rehab Assist has written to health facilities providing further detail about this issue and the recall procedure. If you require further information, call Rehab Assist on 1300 364 534 or 03 9729 7978.
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.