GE Healthcare, LOGIQ e Ultrasound System
Medical device recall Z-1849-2013. Published in FDA’s Enforcement Report on Aug 7, 2013.
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 Aug 7, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 31 states named
- 588 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 became aware of a potential issue associated with the LOGIQ e system. Image data from one patient has the potential to be linked to the patient ID of another patient.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, LOGIQ e Ultrasound System. The LOGIQ i/e and Vivid e is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transesophageal, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.
588, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Mfg Lot or Serial # 223133WX0 223134WX8 223135WX5 223136WX3 223137WX1 224634WX6 224635WX3 224636WX1 224637WX9 224638WX7 224639WX5 224640WX3 224641WX1 224642WX9 224643WX7 224644WX5 224645WX2 224786WX4 224787WX2 224788WX0 224789WX8 224790WX6…
Every code shown here, 2,000 characters
Mfg Lot or Serial # 223133WX0 223134WX8 223135WX5 223136WX3 223137WX1 224634WX6 224635WX3 224636WX1 224637WX9 224638WX7 224639WX5 224640WX3 224641WX1 224642WX9 224643WX7 224644WX5 224645WX2 224786WX4 224787WX2 224788WX0 224789WX8 224790WX6 224791WX4 224792WX2 224793WX0 224794WX8 224795WX5 224796WX3 224797WX1 224798WX9 224799WX7 224800WX3 224801WX1 224802WX9 224803WX7 224804WX5 224805WX2 224806WX0 224807WX8 224808WX6 224951WX4 225010WX8 225011WX6 225012WX4 225013WX2 225014WX0 225015WX7 225143WX7 225144WX5 225145WX2 225146WX0 226933WX0 226934WX8 226935WX5 226936WX3 226937WX1 227218WX5 227219WX3 227221WX9 227222WX7 227223WX5 227224WX3 227225WX0 227226WX8 227227WX6 227228WX4 227229WX2 227230WX0 227231WX8 227232WX6 227233WX4 227279WX7 227280WX5 227281WX3 227282WX1 227283WX9 227284WX7 227285WX4 227286WX2 227287WX0 227288WX8 227574WX1 227575WX8 227576WX6 227577WX4 227578WX2 228256WX4 228257WX2 228258WX0 228259WX8 228260WX6 228772WX0 228773WX8 228774WX6 228775WX3 228776WX1 228777WX9 228778WX7 228779WX5 228780WX3 229786WX9 229787WX7 229790WX1 229791WX9 229792WX7 229793WX5 231677WX6 231678WX4 231679WX2 231680WX0 231681WX8 231682WX6 231683WX4 231684WX2 231685WX9 231686WX7 231687WX5 231688WX3 231689WX1 231690WX9 232467WX1 232468WX9 232470WX5 232471WX3 232472WX1 232473WX9 232474WX7 232500WX9 232501WX7 232502WX5 232503WX3 232504WX1 232505WX8 232506WX6 233383WX9 233384WX7 233385WX4 233386WX2 233387WX0 233388WX8 233389WX6 233390WX4 233391WX2 233392WX0 233393WX8 233394WX6 233395WX3 233396WX1 234475WX2 235601WX2 235602WX0 235603WX8 235604WX6 235605WX3 236395WX0 236396WX8 236397WX6 236398WX4 236399WX2 237120WX1 237121WX9 237122WX7 237123WX5 237124WX3 237617WX6 237618WX4 237619WX2 237620WX0 237621WX8 238640WX7 238641WX5 238642WX3 238643WX1 238644WX9 240405WX1 240406WX9 240407WX7 240408WX5 240409WX3 240410WX1 240411WX9 240412WX7 240413WX5 240414WX3 240415WX0 240416WX8 242064WX4 242065WX1 242070WX1 242071WX9 242073WX5 242074WX3 242075WX0 242076WX8 242077WX6 242078WX4 242499WX2 242500WX7…
FDA’s list runs to 5,899 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 states of AL, AK, AZ, AR, CA, CO, DE, FL, GA, ID, IL , IA, MD, MA, MI, MS, MO, NJ, NM, NY, NC, OH, PA, RI, SC, TN,TX, UT,VT, VA and WI., and the countries of ARAB EMIRATES, AUSTRALIA, AUSTRIA, BELGIUM, DENMARK, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, HONG KONG, INDIA, ITALY, JAPAN, NETHERLANDS,NEW ZEALAND, NORWAY, POLAND, RUSSIA, SAUDI ARABIA, SINGAPORE,SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND and UNITED EMIRATES.
The states and territories these words name
31 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Delaware
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Massachusetts
- Maryland
- Michigan
- Missouri
- Mississippi
- North Carolina
- New Jersey
- New Mexico
- New York
- Ohio
- Pennsylvania
- Rhode Island
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Wisconsin
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 Nov 9, 2012.
- FDA classified it on Aug 1, 2013.
- FDA’s Enforcement Report published it on Aug 7, 2013.
- FDA terminated it on Sep 15, 2014.
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: Visit.
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 5,899 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.