Skip to content
Recall Observatory FDA recall evidence

Device product

SW Bari Lift & Transfer, Model Number 38060000

Z-1595-2024

January 25, 2024

Class II

Product summary

Firm
Raye's Inc.
Event
Event 93887
Status
Ongoing
Classification
Class II
Quantity
1,149 units
Official record key
device-enforcement:Z-1595-2024

Official wording

Reason: 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.

Code information: UDI/DI 00845699001040, All serial numbers

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Australia, UK.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.