Urgent Medical Device Recall: Arjo Sara Plus lift- Field Correction

Our records indicate you may be in possession of one or more Sara Plus lifts equipped with a Printed Circuit Board (PCB) that is prone to damage when the product is used with depleted batteries.  We are contacting you in order to notify you of a required corrective action on the identified affected device(s).

Using depleted batteries may result in overheating of the PCB transistors which may cause smoking and/or ignition.  Other factors contributing to this issue include using the lift in a humid environment, spraying the lift covers with liquid, and overlading the lift.

This issue has the potential to cause harm to the patient and/or caregiver such as a smoke inhalation hazard and/or a burn hazard.  Arjo has received two (2) reports of the Sara Plus lift smoking and igniting, however, there are no reports of any of any health consequences to either the patients or their caregivers due to this failure mode.

The ignition can be preceded by white smoke coming out of the lift.  If you notice smoke, stop using your Sara Plus lift immediately, push Emergency Stop Button, and remove the battery from the battery socket to prevent any further failure.

If you have any further questions or require assistance, please contact Arjo directly at 800-323-1245 or via email at ArjoCustomer.Response-US@arjo.com.  The recall notice has been submitted to the FDA.