The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Products
Hillrom Liko Multirall 200 Overhead Lift
- Model Number, Product Codes, Catalog or Lot numbers:
- 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)
- Manufacturing Dates: 12/2000 to 10/2020
- Distribution Dates: December 17, 2000 to October 1, 2020
- Devices Recalled in the U.S.: 11,60
- Date Initiated by Firm: December 18, 2020
Device Use
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.
Reason for Recall
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.
Who May be Affected
- Health care providers using the affected Hillrom device
- Patients and bystanders using the affected Hillrom device
What to Do
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
Hillrom or an official Hillrom distributor will contact customers to plan replacement of the Q-Link strap with the Q-Link 2 strap once units have been identified and the response form is returned.
Contact Information
Customers who have questions about the notification should contact their local sales representative or Hillrom Technical Support by phone at (812) 934-7777 from 8 am to 7 pm ET Monday through Thursday and. 8 am to 6 pm EST on Friday.
Additional Resources
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.
