Food, drugs, devices › GE Healthcare
Device recall: GE Healthcare, Treadmill T2100. For Exercise Testing, facilitating accurate blood pressure measurements and exercise tes
GE Healthcare (Waukesha, WI) initiated this device recall on 12 Mar 2015; FDA lists 1 product record under event 71449, classified Class II.
FDA defines Class II as 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. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 29 Sep 2017. Initiation: voluntary: firm initiated. GE Healthcare has 44 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
GE Healthcare, Waukesha, WI.
Reason for recall
"GE Healthcare has recently become aware of a potential safety issue due to uncontrolled motion of the walking belt on your T2100 Treadmill."
Distribution
"Nationwide Distribution including Guam, DC, and Puerto Rico. OUS: VIET NAM, VENEZUELA, UZBEKISTAN, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TRINIDAD & TOBAGO, THAILAND, TAIWAN EL…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1825-2015 | GE Healthcare, Treadmill T2100. For Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0-13.5 miles per hour. | 11,423 (5,540 units US, 5,883 units OUS | Class II | Terminated | 1 Jul 2015 |
Context
Other enforcement events for GE Healthcare
All 44 events for GE Healthcare
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "GE Healthcare has recently become aware of a potential safety issue due to uncontrolled motion of the walking belt on your T2100 Treadmill."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Distribution including Guam, DC, and Puerto Rico. OUS: VIET NAM, VENEZUELA, UZBEKISTAN, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TRINIDAD & TOBAGO, THAILAND, TAIWAN EL…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 29 Sep 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.