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Recall Observatory FDA recall evidence

Device product

Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient lifts

Z-1486-2024

February 23, 2024

Class II

Product summary

Firm
Human Care Hc Sweden Ab
Event
Event 94140
Status
Ongoing
Classification
Class II
Quantity
10
Official record key
device-enforcement:Z-1486-2024

Official wording

Reason: Patient lift hanger bar may come loose, which could potentially pose risks to patients.

Code information: UDI-DI: 7331599999943 Products manufactured between May 2023 and October 2023. Serial Numbers: 236229060002, 236229060005, 236232010015, 236229070004, 236232010006, 236229060003, 236229060009, 236229060006, 236232010005, 236232010003

Distribution pattern: US Nationwide distribution in the states of TX, IL, OK, CA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Patient lift hanger bar may come loose, which could potentially pose risks to patients.