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Recall Observatory FDA recall evidence

Device product

Sit to Stand STS500 Patient Lift

Z-1205-2023

February 03, 2023

Class II

Product summary

Firm
Med-Mizer, Inc.
Event
Event 91695
Status
Ongoing
Classification
Class II
Quantity
37 units
Official record key
device-enforcement:Z-1205-2023

Official wording

Reason: Risk of boom pivot failing due to the nut securing the boom becoming loose and the bolt to be unsecure to the flange on the side.

Code information: UDI-DI: 00852195007353; Serial No.: STS500000, STS500001, STS500002, STS500003, STS500004, STS500005, STS500006, STS500007, STS500008, STS500009, STS500010, STS500011, STS500012, STS500013, STS500014, STS500015, STS500016, STS500017, STS500018, STS500019, STS500020, STS500021, STS500022, STS500023, STS500024, STS500025, STS500026, STS500027, STS500028, STS500029, STS500030, STS500031, STS500032, STS500033, STS500034, STS500035, and STS500036.

Distribution pattern: Awaiting consignee list from the recalling firm.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Risk of boom pivot failing due to the nut securing the boom becoming loose and the bolt to be unsecure to the flange on the side.