GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging.
Medical device recall Z-1488-2014. Published in FDA’s Enforcement Report on Apr 30, 2014.
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 Apr 30, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 18 states named
- 447 (81US, 366 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 where the probe power surveillance settings for 4 probes (C1-5-D, C2-9-D, IC5-9-D and M5Sc-D) are incorrect. This may result in a situation where probes can overheat.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging.
447 (81US, 366 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 # System ID 0000000VE90667 VE9000667 0000000VE90680 VE9000680 0000000VE90878 VE9000878 0000000VE91045 VE9001045 0000000VE91821 VE9001821 0000000VE91826 VE9R001826 0000000VE92470 VE9R002470 0000000VE93780 VE9R003780…
Every code shown here, 1,993 characters
Mfg Lot or Serial # System ID 0000000VE90667 VE9000667 0000000VE90680 VE9000680 0000000VE90878 VE9000878 0000000VE91045 VE9001045 0000000VE91821 VE9001821 0000000VE91826 VE9R001826 0000000VE92470 VE9R002470 0000000VE93780 VE9R003780 0000000VE94119 VE9R004119 0000000VE94120 VE9R004120 0000000VE94291 VE9R004291 0000000VE94521 VE9004521 0000000VE94736 VE9R004736 0000000VE94790 VE9R004790 0000000VE94876 VE9R004876 0000000VE95024 VE9R005024 0000000VE95025 VE9R005025 0000000VE95027 VE9R005027 0000000VE95028 VE9R005028 0000000VE95222 VE9R005222 0000000VE95226 VE9R005226 0000000VE95271 VE9R005271 0000000VE95302 VE9R005302 0000000VE95319 VE9R005319 0000000VE95558 VE9R005558 0000000VE95597 VE9R005597 0000000VE95599 VE9R005599 0000000VE95604 VE9R005604X 0000000VE95654 VE9005654 0000000VE95908 VE9005908 0000000VE95949 VE9005949 0000000VE95960 VE9005960 0000000VE95969 VE9005969 0000000VE96001 VE9006001 0000000VE96004 VE9006004 0000000VE96005 VE9006005 0000000VE96008 VE9006008 0000000VE96009 VE9006009 0000000VE96010 VE9006010 0000000VE96020 VE9006020 0000000VE96022 VE9006022 0000000VE96138 0000000VE96185 VE9006185 0000000VE96186 VE9006186 0000000VE96187 VE9006187 0000000VE96188 VE9006188 0000000VE96189 VE9006189 0000000VE96190 VE9006190 0000000VE96191 VE9006191 0000000VE96193 VE9006193 0000000VE96194 VE9006194 0000000VE96210 VE9006210 0000000VE96211 VE9006211 0000000VE96212 VE9006212 0000000VE96232 VE9006232 0000000VE96233 VE9006233 0000000VE96234 VE9006234 0000000VE96235 VE9006235 0000000VE96281 VE9006281 0000000VE96282 VE9006282 0000000VE96310 VE9006310 0000000VE96312 VE9006312 0000000VE96357 VE9006357 0000000VE96359 VE9006359 0000000VE96360 VE9006360 0000000VE96361 VE9006361 0000000VE96474 VE9006474 0000000VE96475 VE9006475 0000000VE96477 VE9006477 0000000VE96566 VE9006566 0000000VE96567 VE9006567 0000000VE96568 VE9006568 0000000VE96569 VE9006569 0000000VE96570 VE9006570 0000000VE96571 VE9006571 0000000VE96657 VE9006657 0000000VE96678 VE9006678 0000000VE96685 VE9006685…
FDA’s list runs to 11,093 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.
USA Nationwide Distribution in the states of: CA, CO EL, GA, IN, KS, KY , LA, MA, MI, MO, MT, NY, NM, NV, US: OH, TX, VA, WI. OUS: ARABIC EMIRATES, AUSTRALIA, AUSTRIA, BELGIUM, COLOMBIA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, INDIA,IRELAND, ITALY, JAPAN, KOREA, NETHERLAND, NORWAY, POLAND, PORTUGAL, RUSSIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN.
The states and territories these words name
18 states and territories.
Every one of them
- California
- Colorado
- Georgia
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Michigan
- Missouri
- Montana
- New Mexico
- Nevada
- New York
- Ohio
- Texas
- Virginia
- 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 Mar 27, 2014.
- FDA classified it on Apr 22, 2014.
- FDA’s Enforcement Report published it on Apr 30, 2014.
- FDA terminated it on Jan 14, 2015.
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 11,093 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.