Z-0064-2017 Class II Terminated

Recalled by Winco Mfg., LLC — Ocala, FL

Recall Details

Product Type
Devices
Report Date
October 19, 2016
Initiation Date
June 29, 2016
Termination Date
September 27, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
264 Stretcher Chairs

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.

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.

Code Information

All identified serial numbers.