FDA-Device2016-10-19Class II
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.
Winco Mfg., LLC
Hazard
Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications.
Sold states
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.
Affected count
264 Stretcher Chairs
Manufactured in
5516 SW 1st Ln, N/A, Ocala, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0064-2017Don't want to check this manually?
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