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U.S. Department of Health and Human Services

Class 2 Device Recall Swift Mobil Shower Chair

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 Class 2 Recall
Swift Mobil Shower Chair
see related information
Date Posted July 25, 2013
Recall Status1 Open
Recall Number Z-1807-2013
Recall Event ID 65401
Product Classification Chair, Adjustable, Mechanical - Product Code INN
Product Swift Mobil shower chair, Swift Mobil 160 shower chair, and Swift Mobil Tilt shower chair. Height adjustable four wheeled shower chairs for persons of various weights.
Code Information Affected Serial numbers: 3829 to 11028 (same series for all Swift Mobil products)
Recalling Firm/
Manufacturer
Etac Supply Center Ab
Langgatan 12
Anderstorp
Manufacturer Reason
for Recall
Etac is voluntarily conducting a field correction of the Etac Swift Mobil shower chair. If the Swift Mobil shower chair loses a caster and thus becomes instantly unstable, there is potiential risk for harm or injury.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control
Action Etac sent an "URGENT FIELD CORRECTION" letter dated May 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.
Quantity in Commerce 7200 internationally
Distribution International distribution: Austria, Australia, Belgium, Brazil, Canada, Czech Republic, Denmark, Esonia, Finland, France, Great Britain, Germany, Greece, Hong Kong, Ireland, Isreal, Iceland, Italy, Kingdom of Bahrain, Kuwait, Lithuania, Netherlands, Norge, New Zealand, Spain, Switzerland, Sweden, and United Arab Emirates.
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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