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Recall Observatory FDA recall evidence

Device product

Drop Arm Versamode"

Z-1353-2021

March 24, 2021

Class II

Product summary

Firm
Gf Health Products
Event
Event 87606
Status
Terminated
Classification
Class II
Quantity
66 units
Official record key
device-enforcement:Z-1353-2021

Official wording

Reason: The front casters on the 6810A Lumex Drop Arm Versamode are incorrect.

Code information: Model: 6810A; Device Identifier: M36868101; and Lot number: BMW316BS

Distribution pattern: Distributed nationwide to CA, WI, PA, IL, and TX. Distributed internationally to Mexico and Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The front casters on the 6810A Lumex Drop Arm Versamode are incorrect.