FDA MedWatch - Liko Multirall 200 Overhead Lift by Hillrom: Class I Recall - Due to Failure to Properly Attach Q-Link Strap Lock (Also Known as Q-Link 1 Strap Lock) to S65 Hook

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: FDA MedWatch - Liko Multirall 200 Overhead Lift by Hillrom: Class I Recall - Due to Failure to Properly Attach Q-Link Strap Lock (Also Known as Q-Link 1 Strap Lock) to S65 Hook AUDIENCE: Patient, Health Professional, Risk Manager ISSUE: Hillrom is recalling the Liko Multirall 200 Overhead Lift due to customer reports that the Q-link strap lock does not attach to the S65 carriage hook as it should. If the strap lock does not attach, the motor or the patient may fall. Use of the affected product may cause adverse events such as serious injury and death. There have been 34 complaints about this device issue and 22 reports of serious injuries. Two deaths have been reported. For more information about the model numbers, product codes, catalog and lot numbers click on the red button "Read Recall" below. BACKGROUND: The Liko Multirall 200 Overhead Lift is a general-purpose lift to move patients from room to room. This lift is part of the the Multirall 200 overhead lift system which has an overhead lift motor, the S65 rail carriage hook, and a Q-link strap. The multirall system is used in health care settings like nursing homes, rehabilitation facilities and hospitals. RECOMMENDATION: On December 18, 2020, Hillrom sent an Urgent Medical Device Correction letter to all affected customers providing the following instructions for health care providers: Inspect each Multirall installations in your facility to see which category (A, B or C) it belongs to Category A: Multirall installations are used with any other room to room accessories such as the Universal SlingBar 350 R2R, 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 Fill out the response form provided with the letter and return it to Hillrom (MOD1322@hillrom.com) or Hillrom distributor within one month Share this notice to other organizations as appropriate. Maintain awareness of this notice and additional resources for an appropriate period to ensure effectiveness Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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