Z-0064-2017Class II

TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study Stretcher-Chair. Intended use is to provide...

Name: Z-0064-2017 TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study Stretcher-Chair. Intended use is to provide...
Creator: Winco Mfg., LLC
Published: 2016-06-29
License: https://open.fda.gov/license/

Champion Mfg, Inc. / initiated 2016-06-29 / Terminated / root cause: manufacturing process

FDA source

Winco Mfg., LLC began a recall of TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study Stretcher-Chair. Intended use is to provide the caregiver a single platform for receiving... on 2016-06-29. FDA classified it as Class II and gives the reason as "Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0064-2017
Classification: Class II
Status: Terminated
Initiated: 2016-06-29
Posted: 2016-10-10
Terminated: 2017-09-27
Recalling firm: Champion Mfg, Inc.
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.
Product code: FPP Stretcher, Hand-Carried
Reason for recall: Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications.
Root cause tag: manufacturing process
FDA root cause: 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 [email protected]
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.
Product codes and lots: All identified serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0064-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0064-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-19	2016-10-09
Z-0065-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-19	2016-10-09
Z-0066-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-19	2016-10-09

Product code FPP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)