Recall Z-2291-2016 ยท FSA Lift, Patient, Non-Ac-Powered
Moller Vital
Molift Air 205, Molift Air 205 Propulsion, Molift Air IRC, Molift Air 205 IRC Propulsion, Molift Air 300, Molift Air 300 Propulsion, Molift Air 300 IRC, Molift Air 300 IRC Propulsion Molift Air is a ceiling hoist used to lift and transfer immobilized patients in various situations. The coupling that holds the suspension is fixed to the lifting belt by a bolt through an aluminum housing. The bolt i
| Date | Jul 26, 2016 (initiated Jun 24, 2016) |
| Status | Terminated |
| Reason | Potential for the bolt on the suspension coupling on the Molift Air to come loose from the housing. |
| Root cause | Device Design |
| Action | Moller Vital sent a Field Safety Corrective Action on June 22, 2016. Field correction instructions were provided to affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to read the instruction, and return the recipient confirmation, report all serial numbers distributed in their region/country to Etac Supply Gjovik, order the upgrade kit from Etac Supply Gjovik, Customers were also instructed to follow up with the customers and users and confirm that all hoists in their market are upgraded. Customers wi |
| Quantity | 516 units (374 US) |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to SZ, TR, BE, CH, DE, DK, ES, FI, FR, GB, IS LV, NL, NO, SE, SI, AU, CN, IL, JP, NZ, IN, QA, PE, AE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.