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U.S. Department of Health and Human Services

Class 1 Device Recall Liko Multirall (a Hill Rom Company)

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  Class 1 Device Recall Liko Multirall (a Hill Rom Company) see related information
Date Initiated by Firm December 18, 2020
Date Posted January 29, 2021
Recall Status1 Terminated 3 on September 26, 2023
Recall Number Z-0925-2021
Recall Event ID 87053
Product Classification Lift, patient, non-ac-powered - Product Code FSA
Product 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)
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
Recalling Firm/
Manufacturer		 Hill-Rom, Inc.
1069 State Road 46 E
Batesville IN 47006-7520
For Additional Information Contact Hillrom Technical Support
812-934-7777
Manufacturer 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
FDA Determined
Cause 2		 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 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
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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