FDA-Device2020-10-21Class II
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.
Handicare AB
Hazard
Carry bar may detach during use of mobile lifts and ceiling lifts equipped with the Swifthook component.
Sold states
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.
Affected count
6716 units (585 in US; 6131 in OUS)
Manufactured in
Maskinvagen 17, N/A, Lulea, N/A, Sweden
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0096-2021Don't want to check this manually?
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