FDA recall Z-0096-2021

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.

Reason for recall

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

Distribution

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.

Key facts

Status

Terminated

Initiation date

2020-08-21

Report date

2020-10-21

Termination date

2023-01-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lulea, N/A, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0096-2021