Recall Z-0096-2021 ยท FSA Lift, Patient, Non-Ac-Powered
Handicare AB
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.
| Date | Aug 21, 2020 |
| Status | Terminated |
| Reason | Carry bar may detach during use of mobile lifts and ceiling lifts equipped with the Swifthook component. |
| Root cause | Use error |
| Action | Handicare USA issued an field safety notification on August 21, 2020. It states the following. Users of affected units are urgently requested to perform the following actions for devices in their possession without delay upon receiving the field notice. It is advised to cease using the Swifthook. Instead, the carry bar can be mounted directly onto the mobile or ceiling lift. This action will eliminate the possibility of incorrectly mounting the Swifthook while gaining the advantage of increased lift height capacity. The Swifthook should be destroyed. 1. Remove the Swifthook from the carry |
| Quantity | 6716 units (585 in US; 6131 in OUS) |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.