Recall Z-0640-2022 ยท FSA Lift, Patient, Non-Ac-Powered
Hill-Rom, Inc.
Liko Mobile Lifts: Primarily intended for use in nursing homes LikoM230 Model: 2050015
| Date | Dec 23, 2021 |
| Status | Open, Classified |
| Reason | Missing bushing on Liko M220 and M230 causing wear and potential for patient falling |
| 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 Te |
| Quantity | 1215 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.