Health Canada — Medical Devices · Canada · 2022-04-04 · Type II
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Reported risk: Since Nov, 2020, Arjo has become aware of 2 customer complaints on smoke and flames coming out of the lift. In both events the extent of flames was limited to the lift and no health consequences were reported. The product (devices and spare parts shipped between Oct 2016 - Jan 2022) in the market are recognized as potentially affected with the risk of cover ignition. The investigation has revealed that the failure is attributed to the insufficient design of Sara Plus PCB that is prone to damage during use. Recall start date: Mar 28, 2022
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