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Recall Observatory FDA recall evidence

Device product

TransMotion Medical, TMM5 Series Mobile Surgical 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.

Z-0066-2017

June 29, 2016

Class II

Product summary

Firm
Winco Mfg., LLC
Event
Event 74922
Status
Terminated
Classification
Class II
Quantity
264 Stretcher Chairs
Official record key
device-enforcement:Z-0066-2017

Official wording

Reason: Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications.

Code information: All identified serial numbers.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications.