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.

Recall number

Z-0096-2021

Recalling firm

Handicare AB

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.

Status

Terminated

Initiated

2020-08-21

Posted

not on file

Terminated

2023-01-30

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 bar using the appropriate Allen key (5 mm) and wrench (13 mm); 2. 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; 3. 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. Each 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 28, 2020. For any questions regarding this FSN, please contact FieldAction.NorthAmerica@handicare.com or Laren Mcintosh, Director of Quality, North America.

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, Poland, Portugal, Qatar, Saudi Arabia, Spain, Sweden, Taiwan the Netherlands, UAE, UK.

Lot, serial or model codes

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)

510(k) numbers

not on file

PMA numbers

not on file

Product code

FSA

Firm FEI

3009481053

Firm city

Lulea

Firm state

not on file

Firm country

Sweden

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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