SwiftHook sold as the following: a. Individually as SwiftHook b. Included with Vega505EE mobile...
FDA Device Recall #Z-0096-2021 — Class II — August 21, 2020
Recall Summary
| Recall Number | Z-0096-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 21, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Handicare AB |
| Location | Lulea, N/A |
| Product Type | Devices |
| Quantity | 6716 units (585 in US; 6131 in OUS) |
Product Description
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 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.
Lot / 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)
Other Recalls from Handicare AB
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0014-2018 | Class II | Carina Mobile Lifts, Models: a) Carina350EM,... | Jul 28, 2016 |
| Z-1943-2020 | Class II | EVA Floor Lifts, Model Numbers: 400, 450, 600 | Jun 15, 2016 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.