ClearanceBrief
Recall Z-1807-2013 ยท INN Chair, Adjustable, Mechanical

Etac Supply Center Ab

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.

DateJul 25, 2013 (initiated May 23, 2013)
StatusTerminated
ReasonEtac 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.
Root causeComponent change control
ActionEtac 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.
Quantity7200 internationally
DistributionInternational 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, a
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.