Recall record at a glance
| Official record | Z-2291-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Moller Vital |
| Report date | Aug 3, 2016 |
| Recall initiation date | Jun 24, 2016 |
| Quantity | 516 units (374 US) |
| Location | Gjovik, N/A, Norway |
Official 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
Why the product was recalled
Potential for the bolt on the suspension coupling on the Molift Air to come loose from the housing.
Distribution information
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
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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