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Recall Observatory FDA recall evidence

Device 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.

Z-0096-2021

August 21, 2020

Class II

Product summary

Firm
Handicare AB
Event
Event 86318
Status
Terminated
Classification
Class II
Quantity
6716 units (585 in US; 6131 in OUS)
Official record key
device-enforcement:Z-0096-2021

Official wording

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

Code information: a. Model number: 70200008; b. Model number: 60600003; Serial Numbers 660311979, 660311759, 010733176902042221660312235, 660311299, 660312299 660311338, 7331769020422, 660311817,660311846, 660311847, 660311848, 6603118540422, 660311855, 6603118560422, 660311849, 660311850, 660311851, 660311852, 660311877, 660311878, 660311880, 660311941, 660311942, 660311968, sales order number 100931 (serial number could not be located)

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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