{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "183334", "product_res_number": "Z-0096-2021", "event_date_initiated": "2020-08-21", "event_date_created": "2020-10-09", "recall_status": "Terminated", "event_date_terminated": "2023-01-30", "res_event_number": "86318", "product_code": "FSA", "product_description": "SwiftHook sold as the following:\na. Individually as SwiftHook\nb. Included with Vega505EE mobile lifts\nProduct Usage: The mobile lifts are intended to assist people with functional impairments in scenarios involving physical positioning.", "code_info": "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)", "firm_fei_number": "3009481053", "recalling_firm": "Handicare AB", "address_1": "Maskinvagen 17 17 maskinvagen", "city": "Lulea", "country": "Sweden", "reason_for_recall": "Carry bar may detach during use of mobile lifts and ceiling lifts equipped with the Swifthook component.", "root_cause_description": "Use error", "action": "Handicare USA issued an field safety notification on August 21, 2020. It states the following.\n\nUsers of affected units are urgently requested to perform the following actions for devices in their possession without delay upon receiving the field notice.\n\nIt 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.\n\n1. Remove the Swifthook from the carry bar using the appropriate Allen key (5 mm) and wrench (13 mm);\n\n2. Remove the fasteners from the mobile lift's boom using two 13 mm wrenches. In the case of a ceiling lift, remove the fasteners from the ceiling lift's H-adapter using two 4 mm Allen Keys;\n\n3. Attach the carry bar directly to the mobile lift's boom. Check that the lock nuts are undamaged and still offers resistance to tightening by hand, and if not, replace with new nuts (DIN985 M8fzb lock nut). In the case of a ceiling lift, use two 4 mm Allen Keys and tighten well by hand.\n\nEach customer is required to communicate the content of the field safety notice to all end users and complete the response form, which shall be returned by email to Handicare USA using provided contact details no later than September\n28, 2020.\n\nFor any questions regarding this FSN, please contact FieldAction.NorthAmerica@handicare.com or Laren Mcintosh, Director of Quality, North America.", "product_quantity": "6716 units (585 in US; 6131 in OUS)", "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\nthe Netherlands, UAE, UK.", "openfda": { "k_number": [ "K844976", 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