Recall Z-0925-2021 ยท FSA Lift, Patient, Non-Ac-Powered
Hill-Rom, Inc.
Liko Multirall 200 overhead lift- overhead lift is a general-purpose lift with the intended use in healthcare, intensive care and rehabilitation. Affected devices: Liko Multirall 200 (product number 3130001) Universal SlingBar 450 R2R (product number 3156095) Universal SlingBar 350 R2R (product number 3156094) Carriage D45 with Double Hook (product number 3136100) Extension belt 300-400 mm (produ
| Date | Jan 29, 2021 (initiated Dec 18, 2020) |
| Status | Terminated |
| Reason | Multirall Q-link strap lock has not been fully engaged in the S65 rail carriage hook by user, leading to the Multirall lift becoming detached from the rail system, potentially resulting in the fall of both the lift motor and the patient |
| Root cause | Device Design |
| Action | Hill Rom issued "Urgent Medical Device Correction" notice on 18 December 2020 to Distributors and End Users. The letter states: Hillrom will perform this field action in two phases. In the interim, you may continue to utilize your medical device. Hillrom will be replacing the Q-link on Multiralls to Q-link II to improve ease of use and mitigate potential risk to patient or caregiver. Phase 1: Users inspect their Multirall installations, fill out the response forms and return it to Hillrom or Hillrom distributor. The serial numbers are stated on the product label attached to the lift. Kindly |
| Quantity | 10470 units Expanded Recall: 154 units |
| Distribution | Worldwide distribution: US (Nationwide) and countries of::AT, AU, BR, CA, CH, CZ, DE, DK, ES, FI, FR, GB, GR, IE, IL, IS, IT, JP, LV, NL, NO, NZ, SE & SK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.