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Handicare AB recalls SwiftHook sold as the following: a. Individually as SwiftHook b. Included with Vega505EE mobile lifts Product Usage:
Recalled October 21, 2020 · FDA recall Z-0096-2021 · Handicare AB
Hazard
Carry bar may detach during use of mobile lifts and ceiling lifts equipped with the Swifthook component. · FDA Class II
Units
6716 units (585 in US; 6131 in OUS)
Sold at
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, Poland, Portugal, Qatar, Saudi Arabia, Spain, Sweden, Taiwan the Netherlands, UAE, UK.
Description
Carry bar may detach during use of mobile lifts and ceiling lifts equipped with the Swifthook component.
Product
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.
Manufacturer(s)
Handicare AB
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →