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