GE Healthcare, Dash 3000/4000/5000
Medical device recall Z-0494-2013. Published in FDA’s Enforcement Report on Dec 26, 2012.
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 Dec 26, 2012. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 119,260 devices 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 issue due to an unexpected loss of Custom Automatic NBP Measurement cycling associated with the Dash 3000/4000/5000 patient monitors.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, Dash 3000/4000/5000. The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash 3000/4000/5000 patient monitor is designed as a bedside, portable, and intra-hospital transport monitor that can operate in all professional medical facilities including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, free-standing surgical centers, and other alternate care facilities. Physiologic data includes, but is not limited to: electrocardiogram, invasive blood pressure, noninvasive blood pressure (NBP), heart rate, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, bi-spectral index, impedance cardiography, oxygen, and anesthetic agents as summarized in the operator’s manual. The Dash 3000/4000/5000 patient monitor is also intended to provide physiologic data over the UNITY NETWORKTM indirectly to clinical information systems (via our Enterprise Gateway) and allow the user to access hospital data at the point-of-care. The information can be displayed, trended, stored, and printed. The Dash 3000/4000/5000 patient monitor was developed to interface with nonproprietary third party peripheral devices that support serial data outputs.
119,260 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
FMI# & Descr: 36080 DASH 3/4/5k Custom Auto NBP System ID (As required) SD010210331GA SD010262074GA SD010262088GA SD010272286GA SD010272290GA SD010272298GA SD010272299GA SD010272300GA SD010272304GA SD010272306GA SD010272307GA SD010272308GA…
Every code shown here, 1,990 characters
FMI# & Descr: 36080 DASH 3/4/5k Custom Auto NBP System ID (As required) SD010210331GA SD010262074GA SD010262088GA SD010272286GA SD010272290GA SD010272298GA SD010272299GA SD010272300GA SD010272304GA SD010272306GA SD010272307GA SD010272308GA SD010272518GA SD010272529GA SD010272531GA SD010272533GA SD010272535GA SD010272536GA SD010272537GA SD010272539GA SD010272541GA SD010272542GA SD010272544GA SD010272545GA SD010272546GA SD010272547GA SD010292708GA SD010292709GA SD010292711GA SD010292836GA SD010292904GA SD010292966GA SD010292968GA SD010292969GA SD010292977GA SD010292978GA SD010292980GA SD010292982GA SD010292984GA SD010292985GA SD010292986GA SD010292987GA SD010292988GA SD010292989GA SD010292990GA SD010292991GA SD010292992GA SD010292993GA SD010292994GA SD010292995GA SD010292996GA SD010292997GA SD010292999GA SD010293000GA SD010293106GA SD010293107GA SD010293108GA SD010293109GA SD010293110GA SD010293113GA SD010293114GA SD010293115GA SD010293116GA SD010293118GA SD010293119GA SD010293120GA SD010293121GA SD010293122GA SD010293123GA SD010293124GA SD010293125GA SD010293126GA SD010293127GA SD010293128GA SD010293129GA SD010293131GA SD010293132GA SD010293133GA SD010293134GA SD010293135GA SD010293136GA SD010293139GA SD010293141GA SD010293142GA SD010293143GA SD010293144GA SD010293145GA SD010293146GA SD010293147GA SD010293148GA SD010303149GA SD010303150GA SD010303152GA SD010303153GA SD010303155GA SD010303156GA SD010303157GA SD010303158GA SD010303159GA SD010303160GA SD010303161GA SD010303162GA SD010303163GA SD010303164GA SD010303165GA SD010303167GA SD010303168GA SD010303169GA SD010303170GA SD010303171GA SD010303172GA SD010303173GA SD010303174GA SD010303175GA SD010303176GA SD010303177GA SD010303178GA SD010303179GA SD010303180GA SD010303181GA SD010303182GA SD010303183GA SD010303184GA SD010303185GA SD010303186GA SD010303188GA SD010303189GA SD010303190GA SD010303191GA SD010303192GA SD010303193GA SD010303194GA SD010303195GA SD010303196GA SD010303290GA SD010303291GA SD010303292GA…
FDA’s list runs to 981,166 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.
Worldwide Distribution -- USA (nationwide) including the countries of AUSTRALIA, ANGOLA,ARGENTINA, AUSTRIA, BAHAMAS, BAHRAIN, BANGLADESH, BELGIUM, BOSNIA HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CUBA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GHANA, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNG ARIA, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAHSTAN, KENYA, KOREA, KUWAIT, LATIVIA, LEBANON, LIBYA, LITHUANIA, MACEDONIA, MALAYSIA, MEXICO, MALTA, MOROCCO, NEPAL, NETHERLAND, NEW ZEALAND, NIGERIA, NORWAY, PAKISTAN, PALESTINIAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN THAILAND, TRINIDAD AND TOBAGO,K TUNISIA, TURKEY, UGANDA, UKRAINE, UNITED ARB EMIRATES , UNITED KINGDOM and URUGUAY
These words name no state.
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 Jun 26, 2012.
- FDA classified it on Dec 16, 2012.
- FDA’s Enforcement Report published it on Dec 26, 2012.
- FDA terminated it on Jun 23, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, LLC, 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 981,166 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
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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.