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Recall Observatory FDA recall evidence

Device product

A-series lift - A625 Manual w/Load Cell & Wi-Fi, Omni Part No. 324124. Prism Medical.

Z-1405-2017

January 30, 2017

Class II

Product summary

Firm
ErgoSafe Products, LLC (DBA) Prism Medical
Event
Event 76351
Status
Terminated
Classification
Class II
Quantity
21
Official record key
device-enforcement:Z-1405-2017

Official wording

Reason: During internal cycle test at max load (625 lbs.) 2 units had straps break prematurely.

Code information: A6MC000110 A6M0001010 A6M0001011 A6M0001012 A6M0001013 A6M0001014 A6M0001015 A6M0001016 A6M0001017 A6M0001018 A6M0001019 A6M0001020 A6M0001021 A6M0001025 A6M0001026 A6M0001029 A6M0001022 A6M0001023 A6M0001024 A6M0001027 A6M0001028

Distribution pattern: Product was distributed to MT and NV; one VA consignee.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    During internal cycle test at max load (625 lbs.) 2 units had straps break prematurely.