Medical device recalls Moderate risk

Handicare AB recalls SwiftHook sold as the following: a. Individually as SwiftHook b. Included with Vega505EE mobile lifts Product Usage: Th…

Recall date
August 21, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0096-2021
FDA classification
Class II
Brand / firm
Handicare AB
Sold / distributed
Worldwide distribution - US Nationwide distribution including in the states of CA, IL, MD, MI, MN, NH, NJ, NY, ON, PA, TX, VA, WA, WI and the countries of Australia, Belgium, Canada, Chile, Denmark, Finland, Germany, Iceland, Ireland, Israel, Japan, Lithuania/ Lathvia, Malaysia, New Zealand, Norway…

Why it was recalled

Carry bar may detach during use of mobile lifts and ceiling lifts equipped with the Swifthook component.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SwiftHook sold as the following: a. Individually as SwiftHook b. Included with Vega505EE mobile lifts Product Usage: The mobile lifts are intended to assist people with functional impairments in scenarios involving physical positioning.

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