| Class 2 Device Recall Swift Mobil Shower Chair | |
Date Initiated by Firm | May 23, 2013 |
Date Posted | July 25, 2013 |
Recall Status1 |
Terminated 3 on October 24, 2014 |
Recall Number | Z-1807-2013 |
Recall Event ID |
65401 |
Product Classification |
Chair, adjustable, mechanical - Product Code INN
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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 Sweden
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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 | 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 |
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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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