FDA Enforcement Class II Ongoing

Liko Mobile Lifts: Primarily intended for use in nursing homes Liko M220, Model 2050010

Recall: Z-0639-2022 · Reported February 23, 2022

Enforcement

Recall Number
Z-0639-2022
Event ID
89414
Classification
Class II
Status
Ongoing
Product Type
Devices
Firm
Hill-Rom, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
February 23, 2022
Initiation Date
December 23, 2021
Classification Date
February 14, 2022
Address
1069 State Road 46 E, N/A, Batesville, IN, 47006-7520, United States

Description

Liko Mobile Lifts: Primarily intended for use in nursing homes Liko M220, Model 2050010

Reason

Missing bushing on Liko M220 and M230 causing wear and potential for patient falling

Code Info

Serial numbers: 5263715-5269464. Manufactured between 2016-DEC-27 and 2021-SEP-01. UDI: 0887761GMN000034U5

Distribution

Worldwide distribution - US Nationwide and the countries of Austria, Austria, Bahrain, Canada, Switzerland, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, Italy, Norway, Saudi Arabia, Sweden, Slovenia, Taiwan (Province of China), South Africa, Oman.

Quantity

5470 units