ETAC A/S
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A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a result of deformation of the materials involved between the lifting bar and the arm of the device. Such deformation can lead to limited mobility in the joint, which prevents proper functionality of the equipment.
Brand Name: Molift Product Name: Molift Mover 300 Model/Catalog Numbers: (1) M1501, (2) M1502, (3) M1504, (4) M15050, (5) M15151, (6) M15001, (7) M15002; Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength. Component: The deformation occurs between the bolt and the fork in the joint connecting the lifting bar and the arm on the Molift Mover.
(1) Model/Catalog Number: M1501; UDI-DI: TBD; Serial Numbers: 601005, 601002, 611506, 621101, 621106, 621104, 621105, 621102, 611505, 611504, 611503, 611502, 611501, 601008, 611507, 601007, 601006, 601001, 621103, 601003, 601004; (2) Model/Catalog Number: M1502; UDI-DI: TBD; Serial Numbers: 611409, 611408, 611407, 611406, 611405, 611404, 611403, 611402, 611401, 611412, 611411, 611410; (3) Model/Catalog Number: M1504; UDI-DI: TBD; Serial Numbers: 600902, 600901, 611303, 611302, 611301; (4) Model/Catalog Number: M15050; UDI-DI: TBD; Serial Numbers: 586003, 586001, 585905, 585903, 585902, 585901, 598605, 586101, 585904, 603602, 591401, 586002, 586006, 586005, 586004, 598608, 598607, 585906, 591601, 598606, 598604, 598602, 598601, 596501, 603601, 598609, 598603; (5) Model/Catalog Number: M15151; UDI-DI: TBD; Serial Numbers: 599703, 599702, 599701; (6) Model/Catalog Number: M15001; UDI-DI: TBD; Serial Numbers: 584401; (7) Model/Catalog Number: M15002; UDI-DI: TBD; Serial Numbers: 591501, 591502;
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →