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

FDA Device Recall #Z-0639-2022 - Class II, December 23, 2021

Recall Summary

Recall Number Z-0639-2022
Classification Class II - Moderate risk
Date Initiated December 23, 2021
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Hill-Rom, Inc.
Location Batesville, IN
Product Type Devices
Quantity 5470 units

Product Description

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

Reason for Recall

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

Distribution Pattern

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.

Lot / Code Information

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

Other Recalls from Hill-Rom, Inc.

Recall # Classification Product Date
Z-0783-2022 Class II (1)Traverse Rail Carrier E-System, wide 31017XX... Jan 14, 2022
Z-0640-2022 Class II Liko Mobile Lifts: Primarily intended for use i... Dec 23, 2021
Z-2600-2021 Class II LikoStretch 1900 Model Number: 3156051 - The co... Aug 11, 2021
Z-2599-2021 Class II Stretch Leveller Model Number: 3156200 - The co... Aug 11, 2021
Z-2601-2021 Class II LikoStretch Mod 600 IC Model Number: 3156065 L... Aug 11, 2021

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.