Swift Mobil shower chair, Swift Mobil 160 shower chair, and Swift Mobil Tilt shower chair. Hei...

FDA Device Recall #Z-1807-2013 — Class II — May 23, 2013

Recall Summary

Recall Number Z-1807-2013
Classification Class II — Moderate risk
Date Initiated May 23, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Etac Supply Center Ab
Location Anderstorp, N/A
Product Type Devices
Quantity 7200 internationally

Product Description

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.

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.

Distribution Pattern

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.

Lot / Code Information

Affected Serial numbers: 3829 to 11028 (same series for all Swift Mobil products)

Other Recalls from Etac Supply Center Ab

Recall # Classification Product Date
Z-2381-2015 Class II Etac Relax wall mounted shower seat The Etac R... Jul 12, 2015
Z-2073-2015 Class II Etac Supporter toilet armrest Etac Supporter t... Jun 15, 2015
Z-2014-2012 Class II Etac¿ Ono Walker, Etac¿ Avant Walker, and Etac... Apr 6, 2012

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.