GE Healthcare, Treadmill T2100
Medical device recall Z-1825-2015. Published in FDA’s Enforcement Report on Jul 1, 2015.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 1, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 3 states named
- 11,423 (5,540 units US, 5,883 units OUS how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
GE Healthcare has recently become aware of a potential safety issue due to uncontrolled motion of the walking belt on your T2100 Treadmill.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Mfg Lot or Serial # SBC05370011SA SBC05370013SA SBC05370014SA SBC05370015SA SBC05370017SA SBC05370018SA SBC05370019SA SBC05370021SA SBC05370022SA SBC05400001SA SBC05400003SA SBC05400004SA SBC05400006SA SBC05400007SA SBC05400008SA…
Every code shown here, 1,994 characters
Mfg Lot or Serial # SBC05370011SA SBC05370013SA SBC05370014SA SBC05370015SA SBC05370017SA SBC05370018SA SBC05370019SA SBC05370021SA SBC05370022SA SBC05400001SA SBC05400003SA SBC05400004SA SBC05400006SA SBC05400007SA SBC05400008SA SBC05400009SA SBC05400010SA SBC05440023SA SBC05440024SA SBC05440025SA SBC05440026SA SBC05440027SA SBC05440028SA SBC05440029SA SBC05440030SA SBC05440032SA SBC05450034SA SBC05450035SA SBC05450036SA SBC05450037SA SBC05450038SA SBC05450039SA SBC05450041SA SBC05450042SA SBC05450043SA SBC05450044SA SBC05450045SA SBC05450046SA SBC05450047SA SBC05450048SA SBC05450049SA SBC05450050SA SBC05450051SA SBC05450054SA SBC05450055SA SBC05450056SA SBC05450058SA SBC05450060SA SBC05450061SA SBC05450062SA SBC05450064SA SBC05450065SA SBC05450067SA SBC05450068SA SBC05450069SA SBC05450072SA SBC05450073SA SBC05450074SA SBC05460075SA SBC05460076SA SBC05460077SA SBC05460078SA SBC05460079SA SBC05460080SA SBC05460081SA SBC05460082SA SBC05460084SA SBC05460085SA SBC05460086SA SBC05460090SA SBC05460091SA SBC05460101SA SBC05460104SA SBC05460108SA SBC05460109SA SBC05470113SA SBC05470115SA SBC05470117SA SBC05470119SA SBC05470120SA SBC05470122SA SBC05470126SA SBC05470130SA SBC05470131SA SBC05470134SA SBC05470136SA SBC05470138SA SBC05470140SA SBC05470141SA SBC05470142SA SBC05470143SA SBC05470144SA SBC05470145SA SBC05470146SA SBC05470147SA SBC05470148SA SBC05480151SA SBC05480152SA SBC05480153SA SBC05480154SA SBC05480155SA SBC05480158SA SBC05480159SA SBC05480161SA SBC05480165SA SBC05480166SA SBC05480168SA SBC05480173SA SBC05480174SA SBC05480175SA SBC05480176SA SBC05480177SA SBC05480181SA SBC05480182SA SBC05480183SA SBC05480184SA SBC05480186SA SBC05480187SA SBC05480189SA SBC05480192SA SBC05490193SA SBC05490194SA SBC05490195SA SBC05490196SA SBC05490198SA SBC05490199SA SBC05490200SA SBC05490202SA SBC05490213SA SBC05490216SA SBC05490217SA SBC05490218SA SBC05490219SA SBC05490220SA SBC05490221SA SBC05490222SA SBC05490223SA SBC05490224SA SBC05490225SA SBC05490227SA SBC05490228SA…
FDA’s list runs to 169,278 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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 SALVADOR, SRILANKA, SPAIN, SOUTH AFRICA, SINGAPORE, SAUDI ARABIA, RUSSIA, PORTUGAL PHILIPPINES, PERU, PARAGUAY, PANAMA, PAKISTAN, NEW ZEALAND, NICARAGUA, NEPAL, MYANMAR, MOROCCO, MEXICO, MARTINIQUE, MALAYSIA, LEBANON, KUWAIT, REPUBLIC OF KOREA, KAZAKHSTAN, JAPAN, JAMAICA, ITALY, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, HON GONG, GERMANY, FRANCE, FINLAND, ETHIOPIA, EGYPT, ECUADOR, DOMINICAN REPUBLIC, COSTA RICA, COLOMBIA, CHINA, CHILE , CAYMAN ISLAND , CANADA, CAMBODIA, BRUNEI DARUSSALAM, BRAZIL, BOLIVIA, BHUTAN, BANGLADESH, BAHRAIN, AUSTRIA, AUSTRALIA, ARGENTINA, ALGERIA.
The states and territories these words name
- District of Columbia
- Guam
- Puerto Rico
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 12, 2015.
- FDA classified it on Jun 22, 2015.
- FDA’s Enforcement Report published it on Jul 1, 2015.
- FDA terminated it on Sep 29, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, of Waukesha, WI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 169,278 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.