• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Molift Smart SWL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Molift Smart SWL see related information
Date Initiated by Firm February 15, 2013
Date Posting Updated May 21, 2013
Recall Status1 Terminated 3 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 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
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 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.
-
-