Recall Z-0064-2017— Winco Mfg., LLC
Class II · Terminated
Class II FDA medical device recall by Winco Mfg., LLC, initiated 2016-06-29, terminated 2017-09-27. FDA's recall record names no specific 510(k) clearance for this event. Product: TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study Stretcher-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: Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications..
- Recalling firm
- Winco Mfg., LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-06-29
- Terminated
- 2017-09-27
- Firm location
- Ocala, FL, United States
Product description
TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study Stretcher-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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.