Agency classClass IIOur severity:High FDA (Devices)·Z-2467-2018·Announced 2018-07-25

GE Medical Systems Recalls T2100 Microflex Drive Treadmill Units

GE Medical Systems is recalling T2100 Microflex Drive Treadmills because unaddressed spare parts may cause uncontrolled walking belt motion during stress tests.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (uncontrolled belt motion on a medical treadmill) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC is recalling 3,721 T2100 Microflex Drive Treadmills (models 2026182-004 and 2026182-002). The recall addresses a performance issue with customer-owned spare parts that was not resolved by a previous safety correction.

If these specific spare parts were installed from customer-owned stock, the treadmill may experience uncontrolled walking belt motion during a stress exercise test. The affected devices were distributed worldwide, including in the United States and numerous international locations.

Healthcare facilities and users should check their treadmill serial numbers against the list provided in the official recall notice. If a device is affected, users should stop using the treadmill and contact GE Medical Systems for further instructions on the safety correction.

The recalled product

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…
Manufacturer: GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
Category: Medical Device — Exercise Equipment
Hazard: uncontrolled-motion
fall-injury
Affected units: 3,721

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Treadmill Model Numbers 2026182-004
2026182-002. Known lot/serial numbers: SBC07152197SA
SBC07372859SA
SJV14412914SA
SBC12038975SA
SBC12169265SA
SJV14052101SA
SJV14092190SA
SBC10376789SA
SBC12079098SA
SBC12079100SA
5460609
5448740
SBC12049021SA
SBC12059040SA
SBC12139235SA
SBC07112098SA
SBC07132153SA
SBC10226425SA
SBC12129213SA

Distribution

Distributed nationwide across the United States.

The notice also names 27 states specifically:

Same manufacturer · GE Medical Systems Ultrasound & Primary Care Diagnostics, LL

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Same hazard · uncontrolled motion