Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1342-2013Class II

Molift Smart 150

Etac A/S / initiated 2013-02-15 / Terminated / root cause: manufacturing process

Moller Vital began a recall of Molift Smart 150 on . FDA classified it as Class II and gives the reason as "The leg spreading mechanism will fail to hoist and collapse if assemble incorrectly by the user". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1342-2013
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Etac A/S
Product
Molift Smart 150
Product code
FSA Lift, Patient, Non-Ac-Powered
Reason for recall
The leg spreading mechanism will fail to hoist and collapse if assemble incorrectly by the user.
Root cause tag
manufacturing process
FDA root cause
Employee error
Action
Molift Group AS issued a Field Safety Notice letter to all affected customers. The letter identified the affected products, problem and actions to be taken to the Smart hoists that are already in use. Customers were instructed to make sure that all affected customers receive this information and encorage to increase attention until the affected product has been upgraded. For questions contact your local Molift representative or Customer Service at: [email protected].
Quantity in commerce
7,555 units subject to review; US: 1,280 units - Foreign: 6,275 units
Distribution
US Nationwide Distribution: CA, FL, GA, ID, IL, KY, MA, ME, MI, MN, NC, NH, NJ, NM, NV, NY, OH, OK, PA, TN, TX, VT, WA and Hawaii. Foreign Distribution:: Australia, Austria; Belgium, Denmark, Finland, France, Germany, Iceland, Israel, Italy, Japan, Netherlands, New Zealand, Norway, Spain, Sverige, Switzerland, United Kingdom.
Product codes and lots
Art #: 0920001 batch 1-62 and 0920002 batch 1-77; Serial Number ranges 022228 to 094103 and 100015 to 12058.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1342-2013
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1342-2013Class IITerminatedVoluntary: Firm initiated
Z-1343-2013Class IITerminatedVoluntary: Firm initiated