Recall Z-0065-2017
Winco Mfg., LLC · initiated June 29, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: All identified serial numbers.
Reason for recall
Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications.
FDA-determined cause: Nonconforming Material/Component
Action taken
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
Details
- Recall number
- Z-0065-2017
- Initiated
- June 29, 2016
- Terminated
- September 27, 2017
- Product code
- FPP – Stretcher, Hand-Carried
- Quantity
- 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.
- Recalling firm
- Winco Mfg., LLC, Ocala, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0064-2017 Class II | TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study Stretcher-Chair.…Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications. | 06/29/2016Terminated |
| Z-0066-2017 Class II | TransMotion Medical, TMM5 Series Mobile Surgical Stretcher -Chair. Intended use is to…Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications. | 06/29/2016Terminated |