About the Recall:
Arjo is initiating an urgent medical device recall on affected Sara Plus lifts equipped with a Printed Circuit Board (PCB) that is prone to damage when the product is used with depleted batteries.
The affected devices include Arjo Sara Plus floor lifts manufactured from October 13, 2016 (originally assembled with an affected HMX1350-1 PCB) through January 13, 2022, along with Arjo Sara Plus floor lifts where the PCB was replaced to HMX1350-1 which may have happened up to March 4, 2022. Other Arjo Sara Plus lifts are unaffected with the risk of PCB damage and are safe to use.
Arjo is recalling these products after receiving two reports of the Sara Plus lift smoking and igniting, however, there are no reports of any health consequences to either patients or their caregivers due to this failure mode.
How to Guide Patients:
Customers who contact AdaptHealth subsidiaries with questions must be informed to contact Arjo directly at 1-800-323-1245.
Impacted customers will receive written notification of the recall with instructions to report affected products and to arrange a visit from an Arjo service engineer to complete the Sara Plus correction with a service kit developed by the manufacturer. Specifically, patients will receive the following instructions as communicated by Arjo:
- Ensure all caregivers and users of the Sara Plus floor lift(s) at your facility are made aware of this Medical Device Recall.
- Locate all potentially affected devices by serial number presented on the table titled “Affected Arjo Sara Plus floor lifts at your facility” found on the Customer Response Form to see which Sara Plus is affected. The serial number can be located on the lift behind the rechargeable battery pack.
- Arjo plans to make the following corrective actions: upgrade the PCB and replace the cover. A product correction by Arjo service technicians is required in order to eliminate the recall issue. These remediations will be performed free of charge.
- Complete and sign the Customer Response Form and return to Arjo at the address provided.
Additional questions can be directed to Arjo Customer Service at 800-323-1245 or via email at ArjoCustomer.Response-US@arjo.com .
Locations with this product on inventory are required to immediately pull it from shelves and quarantine it. Additional inventory handling instructions will be shared in the coming weeks.