Liko Multirall 200 overhead lift- overhead lift is a general-purpose lift with the intended use ...
FDA Device Recall #Z-0925-2021 — Class I — December 18, 2020
Recall Summary
| Recall Number | Z-0925-2021 |
| Classification | Class I — Serious risk |
| Date Initiated | December 18, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Hill-Rom, Inc. |
| Location | Batesville, IN |
| Product Type | Devices |
| Quantity | 10470 units Expanded Recall: 154 units |
Product Description
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 (product number 3136226) Extension belt 400-600 mm (product number 3136227) Extension belt 600-1000 mm (product number 3136228) Extension belt 1000-1400mm (product number 3136229)
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
Distribution Pattern
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.
Lot / Code Information
Serial Numbers: All Multirall 200 with serial number < 6511935 (all devices manufactured before 24SEP2019) Except for the reworked serial numbers listed below: 6511692, 6511701, 6511704, 6511706, 6511713, 6511707, 6511709, 6511719, 6511708, 6511689, 6511702, 6511703, 6511691, 6511694, 6511714, 6511690, 6511383, 6511358, 6511375, 6511386, 6511380, 6511376, 6511365, 6511379, 6511333, 6511356, 6511362, 6511363, 6511357, 6511359, 6511377, 6511378, 6511361, 6511329, 6511327, 6511318, 6511320, 6511793, 6511319, 6511328, 6511336, 6511324, 6511326, 6511325, 6511323, 6511321, 6511334, 6511310, 6511189, 6511312, 6511787, 6511792, 6511748, 6511802, 6511799, 6511797, 6511796, 6511800, 6511185, 6511770, 6511805, 6511810, 6511803, 6511807, 6511772, 6511757, 6511806, 6511804, 6511811, 6511801 EXPANDED RECALL 3/17/2021: The following additional serial numbers have been determined to be affected as a Q-Link 1 Service part may been ordered for it: 651338 6512166 6512306 6512418 6512461 6512524 6512548 6512684 6512822 6511935 6512188 6512319 6512420 6512484 6512525 6512549 6512685 6512823 6511962 6512194 6512321 6512421 6512486 6512528 6512553 6512686 6512825 6511964 6512195 6512330 6512424 6512487 6512529 6512562 6512687 6512829 6511968 6512202 6512336 6512425 6512488 6512530 6512581 6512688 6512831 6511970 6512204 6512338 6512429 6512493 6512531 6512582 6512691 6512833 6512014 6512206 6512340 6512430 6512497 6512532 6512583 6512692 6512838 6512015 6512214 6512341 6512436 6512500 6512533 6512589 6512694 6512839 6512106 6512220 6512342 6512437 6512501 6512534 6512619 6512695 6512840 6512107 6512221 6512345 6512440 6512503 6512535 6512621 6512696 6512882 6512119 6512224 6512356 6512441 6512506 6512540 6512623 6512697 6512886 6512125 6512233 6512406 6512442 6512507 6512542 6512636 6512780 6512932 6512129 6512240 6512408 6512443 6512508 6512543 6512637 6512787 6512943 6512134 6512248 6512410 6512444 6512509 6512544 6512668 6512788 6513042 6512150 6512255 6512412 6512446 6512510 6512545 6512681 6512811 6513043 6512154 6512262 6512415 6512448 6512514 6512546 6512682 6512820 6513089 6512157 6512296 6512417 6512449 6512517 6512547 6512683 6512821 6513092 6542422
Other Recalls from Hill-Rom, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0783-2022 | Class II | (1)Traverse Rail Carrier E-System, wide 31017XX... | Jan 14, 2022 |
| Z-0640-2022 | Class II | Liko Mobile Lifts: Primarily intended for use i... | Dec 23, 2021 |
| Z-0639-2022 | Class II | Liko Mobile Lifts: Primarily intended for use i... | Dec 23, 2021 |
| Z-2600-2021 | Class II | LikoStretch 1900 Model Number: 3156051 - The co... | Aug 11, 2021 |
| Z-2599-2021 | Class II | Stretch Leveller Model Number: 3156200 - The co... | Aug 11, 2021 |
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.