| Class 2 Device Recall Molift Smart 150 | |
Date Initiated by Firm | February 15, 2013 |
Date Posted | May 21, 2013 |
Recall Status1 |
Terminated 3 on July 11, 2014 |
Recall Number | Z-1343-2013 |
Recall Event ID |
64512 |
Product Classification |
Lift, patient, non-ac-powered - Product Code FSA
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Product | Molift 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
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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 |
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 | Subject to recall 1,460 units; US: 175 units; Foreign: 1,285 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 |
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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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