Recall Z-0166-2020 ยท FSA Lift, Patient, Non-Ac-Powered
Community Products, LLC
Rifton E-Pacer, SKU K660, powered lift device
| Date | Mar 21, 2019 |
| Status | Terminated |
| Reason | A design change to the load-bearing quick release buckle renders the springs in the latch mechanism susceptible to fatigue failure after repeated use. |
| Root cause | Nonconforming Material/Component |
| Action | Urgent Medical Device Correction emails were sent to customers beginning on March 21, 2019. Customers were contacted via telephone beginning April 5, 2019. |
| Quantity | 167 |
| Distribution | The products were distributed US nationwide. The products were distributed to the following foreign countries: Foreign Countries: Worldwide, including Canada, United Kingdom, Germany, Japan, Singapore, South Korea, United Arab Emirates, Taiwan, Denmark, Italy, Hong Kong, Ireland, Australia, New Ze |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.