Z-0639-2022Class II
Liko Mobile Lifts: Primarily intended for use in nursing homes Liko M220, Model 2050010
Hill-Rom Inc. / initiated 2021-12-23 / Open, Classified / root cause: manufacturing process
Hill-Rom, Inc. began a recall of Liko Mobile Lifts: Primarily intended for use in nursing homes Liko M220, Model 2050010 on . FDA classified it as Class II and gives the reason as "Missing bushing on Liko M220 and M230 causing wear and potential for patient falling". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0639-2022
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Hill-Rom Inc.
- Product
- Liko Mobile Lifts: Primarily intended for use in nursing homes Liko M220, Model 2050010
- Product code
- FSA Lift, Patient, Non-Ac-Powered
- Reason for recall
- Missing bushing on Liko M220 and M230 causing wear and potential for patient falling
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- HillRom issued Urgent Medical Device Correction Letter (FSCA Identifier: FA 2021-010-002-LUL-001) via third party on 23 December 2021 via UPS Ground Service to Distributors and Direct Users. Letter states reason for recall, health risk and action to take: 1. Review the product label on your Liko M220/M230 to determine if it is impacted by this field action by identifying the manufacturing date of the device (i.e. Manufacturing date between 2016-DEC-27 and 2021 SEP-01). See figure 2. 2. Please periodically inspect your Liko device for damage or wear. Report visible wearing or damage to your Technical Support Team do not use the device until Technical Support can inspect and repair where necessary. 3. Please fill out the attached response form and return it to Hillrom [email protected] within two weeks Please share this Field Safety Notice with your end users and complete the attached response form and return to [email protected] within two weeks. Contact [email protected] to receive an electronic copy of this notification and response form for onward distribution. Action to be taken by the Hillrom: Upon receipt of the response form, identifying potentially impacted devices, Hillrom or an official Hillrom distributor/representative will be in contact to schedule inspection of your device to confirm presence of the bushing. Where it is confirmed the device is missing the bushing, a replacement slingbar with the bushing will be installed. If you have any questions regarding this safety notice, please contact Hillrom Technical Support at 800-445-3720 or [email protected]
- Quantity in commerce
- 5470 units
- 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.
- Product codes and lots
- Serial numbers: 5263715-5269464. Manufactured between 2016-DEC-27 and 2021-SEP-01. UDI: 0887761GMN000034U5
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0639-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0640-2022 | Class II | Ongoing | Voluntary: Firm initiated |
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