Liko Multirall 200 overhead lift- overhead lift is a general-purpose lift with the intended use in healthcare, intensive

FDA device recall Z-0925-2021 · posted 2021-01-29 · Terminated

Recall details

Recalling firm

Hill-Rom, Inc.

Reason for recall

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

Action taken

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 read carefully and take the 2 actions within one month: Action 1: Please inspect each Multirall installation in your facility and identify which category (A, B or C) it belongs to: Category A Multirall installations are used in combination with any of the room to room accessories, Universal SlingBar 350 R2R or Universal SlingBar 450 R2R or room to room rail carriage D45 with Double Hook . Category B Multirall installations are combined with an extension belt. Category C Multirall installations are not combined with any of the accessories in A or B Action 2: Please fill out the attached response form and return it to Hillrom (MOD1322@hillrom.com) within one month. This will provide us with the necessary information to plan phase 2 of the field action. Phase 2: Hillrom or an official Hillrom distributor will contact you to plan replacement. Once you have identified units affected by this field corrective action and you have returned the response form, you will be contacted by Hillrom or an official Hillrom distributor, to schedule the replacement of the Q-link 1, R2R accessories and Extension belts if present in the installations. Please transfer this notice to other organizations as appropriate. Please maintain awareness of this notice and additional resource for an appropriate period to ensure effectiveness. If you have any questions regarding this safety notice

Root cause

Device Design

Status

Terminated

Product code

FSA

Quantity affected

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.

Date initiated

2020-12-18

Date posted

2021-01-29

Date terminated

2023-09-26

Location

Batesville, IN