TransMotion Medical, TMM4 Series Multi-Purpose Treatment Chair. Intended use is to provide the...
FDA Device Recall #Z-0065-2017 — Class II — June 29, 2016
Recall Summary
| Recall Number | Z-0065-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 29, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Winco Mfg., LLC |
| Location | Ocala, FL |
| Product Type | Devices |
| Quantity | 264 Stretcher Chairs |
Product Description
TransMotion Medical, TMM4 Series Multi-Purpose Treatment Chair. Intended use is to provide the caregiver a single platform for receiving, transporting within a facility, performing procedures, recovery and discharge of patients in a monitored outpatient environment.
Reason for Recall
Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications.
Distribution Pattern
Worldwide Distribution -- USA, including AR, CA, CO, CT, FL, GA, IL, KS, LA, MD, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, VA, WA, WI, and Puerto Rico; and the countries of Canada, Australia, Italy, Panama, Switzerland and Taiwan.
Lot / Code Information
All identified serial numbers.
Other Recalls from Winco Mfg., LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0064-2017 | Class II | TransMotion Medical, TMM3 Series Video-Fluorosc... | Jun 29, 2016 |
| Z-0066-2017 | Class II | TransMotion Medical, TMM5 Series Mobile Surgica... | Jun 29, 2016 |
| Z-2400-2015 | Class II | Winco Elite Care Cliner w/Swing Away Arms Stand... | Apr 2, 2015 |
| Z-2392-2015 | Class II | Winco Care Cliner Standart - Steel Casters Onc... | Apr 2, 2015 |
| Z-2395-2015 | Class II | Winco Drop Arm Care Cliner Standard - with Nylo... | Apr 2, 2015 |
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.