Device 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.
Z-0064-2017
Product summary
- Firm
- Winco Mfg., LLC
- Event
- Event 74922
- Status
- Terminated
- Classification
- Class II
- Quantity
- 264 Stretcher Chairs
- Official record key
device-enforcement:Z-0064-2017
Official wording
Reason: Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications.
Code information: All identified serial numbers.
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.
Derived failure modes
-
Unknown
Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications.