Recall Z-2467-2018 · IOL Treadmill, Powered

GE Medical Systems Ultrasound & Primary Care Diagnostics, LL

T2100 Micro flex Drive Treadmill, powered Product Usage: Powered exercise equipment consist of powered devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Specifically the T210 Treadmill is intended for use in Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within

Date	Apr 2, 2018
Status	Terminated
Reason	A performance issue with customer owned spare parts, T2100 Microflex drive (2026182-002 or 2026182-004), was not addressed with a previous safety correction. If these parts were installed from customer owned stock on the T2100 Treadmill, uncontrolled walking belt motion during a stress exercise test could occur.
Root cause	Device Design
Action	GE Healthcare sent an Urgent Medical Device Correction letter dated March 30, 2018 to customers. The letter identified the affected product, problem and actions to be taken. The letter stated that GE Healthcare will correct all affected products at no cost. Customers were asked to complete and return the attached "Customer Response" form via email to DCAR.30085@ge.com and a GE Healthcare representative will contact you to arrange for a correction if necessary. For questions contact GE Healthcare Service at 1-800-437-1171 or your local service Representative.
Quantity	3,721 devices total
Distribution	Worldwide Distribution - US Nationwide in the states of AZ, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MO, NC, NE, NJ, NV, NY, OH, OK, PA, SC, TN, TX, WA, WI. International distribution to Kenya DEMOCRATIC REPUBLIC OF CONGO, ALGERIA, ARGENTINA, Australia, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGL
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.