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FDA (Device enforcement)Recalled 2024-01-25class ii

Raye's Inc.: SW Bari Lift & Transfer, Model Number 38060000

Hazard

Retrospective engineering analysis against current ISO standards for hoists has determined: 1. The device cannot physically perform at maximum documented weight specifications when a factor of safety of two times the maximum load is applied. 2. The device is not equipped with a safety device to ensure a person with disability would not fall in the event of a single-fault condition of the lifting device.

Details from the source

Reason for recall: Retrospective engineering analysis against current ISO standards for hoists has determined: 1. The device cannot physically perform at maximum documented weight specifications when a factor of safety of two times the maximum load is applied. 2. The device is not equipped with a safety device to ensure a person with disability would not fall in the event of a single-fault condition of the lifting device. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, UK. Quantity: 1,149 units Lot/code info: UDI/DI 00845699001040, All serial numbers

UPC codes

00845699001040

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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