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U.S. Department of Health and Human Services

Class 2 Device Recall TransMotion Stretcher Chair

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  Class 2 Device Recall TransMotion Stretcher Chair see related information
Date Initiated by Firm June 29, 2016
Create Date October 10, 2016
Recall Status1 Terminated 3 on September 27, 2017
Recall Number Z-0065-2017
Recall Event ID 74922
Product Classification Stretcher, hand-carried - Product Code FPP
Product 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.
Code Information All identified serial numbers.
Recalling Firm/
Manufacturer		 Winco Mfg., LLC
5516 SW 1st Ln
Ocala FL 34474-9307
For Additional Information Contact Ronald Scott
352-854-2929 Ext. 130
Manufacturer Reason
for Recall		 Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Customers were sent an Urgent: Medical Device Recall notification on 7/12/2016 for the specific models of the TransMotion (TMM) Stretcher chairs. The letter explained the reason for the recall and asked customers to take action. Customers are asked to follow the instruction in the Operator Manual for proper egress. Patients are not allowed to egress from the chair without assistance nor should they be left unattended. The chairs will be repaired on site; and, removal of the chair from service is not required with proper supervision and use. Customers are asked to complete the instructions for the acknowledgement form and return. The firm will contact the customers to arrange for repair. Questions regarding the field correction should be directed to the Customer Care department at 800-237-3377 or 352-854-2929 or e-mail QA-RA@wincomfg.com
Quantity in Commerce 264 Stretcher Chairs
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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