Company:GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
Date of Enforcement Report 7/25/2018
Class lI:

PRODUCT

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 speed range of 0-13.5 miles per hour.
Recall Number: Z-2467-2018

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.

RECALLING FIRM/MANUFACTURER
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL, Milwaukee, WI on 4/2/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
3,721 devices total

DISTRIBUTION
Nationwide and Internationally

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