Arjo announces a voluntary recall of the Sara Plus® floor lift
Arjo is announcing a voluntary recall for its Sara Plus® floor lifts due to the possibility of the printed circuit board overheating, resulting in smoke and/or ignition when using the Sara Plus® floor lift with depleted batteries. There have been no reported injuries. Arjo has reported to relevant authorities in accordance with applicable regulations. The cost for the recall is not material.
The recall involves 4,449 Sara Plus® floor lifts worldwide (of which 1,929 units are in the US), manufactured from October 13, 2016, through January 13, 2022, that could possibly emit smoke or ignite when used with depleted batteries. Arjo is aware of 42 reports where the Sara Plus® floor lift has emitted smoke, and two instances where the Sara Plus® floor lift has ignited. There were no reported injuries. No other Arjo devices are involved in this action.
Arjo’s investigation concluded that 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 overloading the lift. The Safe Working Load is 140 kg (308 lbs) when using the transfer and walking sling for transfer and when using the same sling for walking practice the Safe Working Load is 190 kg (420 lbs). Additionally, Arjo’s investigation concluded that ignition will be often preceded by white smoke coming out of the lift. If smoke is observed, users must stop using the Sara Plus® floor lift immediately and press the Emergency Stop Button, then remove the battery from the battery socket in order to prevent any further failure.
All affected customers have been formally notified via certified or express mail of the Sara Plus® Recall on April 08, 2022. Affected customers received an Urgent Field Safety Notice along with instructions to complete a Customer Response Form and schedule servicing to correct the issue. In the meantime, the Sara Plus® floor lift can continue to be used safely when following the precautionary measures provided in the customer notification, i.e., avoid the use of batteries older than 2 years, check the battery indicator often and change the battery when the indicator shows 3 out of 8 filled segments.
Arjo notified the Food and Drug Administration (FDA) on March 29, 2022 and is voluntarily working with the FDA to ensure that all affected customers are notified of this issue.
Arjo is committed to ongoing product surveillance to assure product safety and reliability.
Any inquiries regarding this action should be directed to the Quality and Regulatory Compliance department using the below referenced toll-free number:
Quality and Regulatory Compliance Department
Maria Nilsson, Acting EVP Marketing Communication & Public Relations
Tel: +46 734 244 515
At Arjo, we believe that empowering movement within healthcare environments is essential to quality care. Our products and solutions are designed to promote a safe and dignified experience through patient handling, medical beds, personal hygiene, disinfection, diagnostics, and the prevention of pressure injuries and venous thromboembolism. With 6,500 people worldwide and 65 years caring for patients and healthcare professionals, we are committed to driving healthier outcomes for people facing mobility challenges. www.arjo.com