Recall Z-1486-2024 ยท FSA Lift, Patient, Non-Ac-Powered
Human Care Hc Sweden Ab
Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient lifts
| Date | Apr 5, 2024 (initiated Feb 23, 2024) |
| Status | Open, Classified |
| Reason | Patient lift hanger bar may come loose, which could potentially pose risks to patients. |
| Root cause | Process control |
| Action | On 2/23/24, Field Safety Notices were emailed to customers who were asked to do the following: 1) Checking the fixation by carefully pulling on the shaft. Should you observe any deviation or irregularity, please inform us promptly. 2) Read and understand this letter and provide a confirmation via email to the address quality@humancaregroup.com In case of recognizing any deviation or irregularity during the fixation control or if in need of additional information email quality@humancaregroup.com On 5/6/24, Field Safety Notices were emailed to customers with additional instructions for distr |
| Quantity | 10 |
| Distribution | US Nationwide distribution in the states of TX, IL, OK, CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.