Liko Mobile Lifts: Primarily intended for use in nursing homes Liko M220, Model 2050010
Summary
The FDA issued a Class II for Liko Mobile Lifts: Primarily intended for use in nursing homes Liko M220, Model by Hill-Rom, Inc.. Reason: Missing bushing on Liko M220 and M230 causing wear and potential for patient falling.
Details
Source
Device Recall
External ID
Z-0639-2022
Action Date
2022-02-23
Status
Ongoing
Category
device
Product Description
Liko Mobile Lifts: Primarily intended for use in nursing homes Liko M220, Model 2050010
Lot/Code Info: Serial numbers: 5263715-5269464. Manufactured between 2016-DEC-27 and 2021-SEP-01. UDI: 0887761GMN000034U5
Quantity Affected: 5470 units
Reason for Recall
Missing bushing on Liko M220 and M230 causing wear and potential for patient falling
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-23
Company
Batesville, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Hill-Rom, Inc. has 10 FDA actions in our database, including 10 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hill-Rom, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hill-Rom, Inc. have FDA actions?
Hill-Rom, Inc. has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0639-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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