Recall Z-2291-2016— Moller Vital
Class II · Terminated
Class II FDA medical device recall by Moller Vital, initiated 2016-06-24, terminated 2017-06-23. FDA's recall record names no specific 510(k) clearance for this event. Product: 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 is hold in place by a rubber cap secured with a small screw. The other end of the lifting belt is fixed to the lifting drum on the motor. The design is identical on both Air 205 and Air 300 in all variants. Reason: Potential for the bolt on the suspension coupling on the Molift Air to come loose from the housing..
- Recalling firm
- Moller Vital
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-06-24
- Terminated
- 2017-06-23
- Firm location
- Gjovik, N/A, Norway
Product description
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 is hold in place by a rubber cap secured with a small screw. The other end of the lifting belt is fixed to the lifting drum on the motor. The design is identical on both Air 205 and Air 300 in all variants
Reason for recall
Potential for the bolt on the suspension coupling on the Molift Air to come loose from the housing.
Data sourced from openFDA. This site is unofficial and independent of the FDA.