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U.S. Department of Health and Human Services

Class 2 Device Recall Molift Smart 150

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 Class 2 Device Recall Molift Smart 150see related information
Date Initiated by FirmFebruary 15, 2013
Date PostedMay 21, 2013
Recall Status1 Terminated 3 on July 11, 2014
Recall NumberZ-1343-2013
Recall Event ID 64512
Product Classification Lift, patient, non-ac-powered - Product Code FSA
ProductMolift Smart 150
Code Information Art #: 0920008; Serial Number range 20941 to 27299.
Recalling Firm/
Manufacturer		 Moller Vital
Hadelandsvegan 2,
P.o. Box 408
Gjovik Norway
Manufacturer Reason
for Recall		The leg spreading mechanism will fail to hoist and collapse if assemble incorrectly by the user.
FDA Determined
Cause 2		Employee error
ActionMolift 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 CommerceSubject to recall 1,460 units; US: 175 units; Foreign: 1,285 units
DistributionUS 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 CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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