Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1807-2013Class II

Swift Mobil shower chair, Swift Mobil 160 shower chair, and Swift Mobil Tilt shower chair. Height adjustable...

Etac Supply Center AB / initiated 2013-05-23 / Terminated

Etac Supply Center Ab began a recall of 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... on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1807-2013
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Etac Supply Center AB
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.
Product code
INN Chair, Adjustable, Mechanical
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 root cause
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.
Product codes and lots
Affected Serial numbers: 3829 to 11028 (same series for all Swift Mobil products)

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1807-2013
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1807-2013Class IITerminatedVoluntary: Firm initiated