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U.S. Department of Health and Human Services

Class 2 Device Recall Molift Smart SWL

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 Class 2 Recall
Molift Smart SWL
see related information
Date Posted May 21, 2013
Recall Status1 Terminated on July 11, 2014
Recall Number Z-1342-2013
Recall Event ID 64512
Product Classification Lift, Patient, Non-Ac-Powered - Product Code FSA
Product Molift Smart 150
Code Information Art #: 0920001 batch 1-62 and 0920002 batch 1-77; Serial Number ranges 022228 to 094103 and 100015 to 12058.
Recalling Firm/
Manufacturer
Moller Vital
Hadelandsvegan 2,
P.o. Box 408
Gjovik
Manufacturer Reason
for Recall
The leg spreading mechanism will fail to hoist and collapse if assemble incorrectly by the user.
FDA Determined
Cause 2
TRAINING: 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: groupsales@molift.com.
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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