Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA.
Medical device recall Z-1779-2017. Published in FDA’s Enforcement Report on Apr 19, 2017.
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 19, 2017. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 971(412 US; 559 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 become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where DICOM Worklist search response time is slow. This issue is limited to certain Vivid Ultrasound systems and can result in the incorrect patient information showing on the screen during the exam. If not detected by the operator, images from the actual (intended) patient will be stored under the incorrect patient after the exam. This issue could lead to misdiagnosis. There have been no injuries reported because of this issue.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA.
971(412 US; 559 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 1 VE95R00100 AU00104 VE95R00104 AU00107 VE95R00107 AU00109 VE95R000109 AU00110 VE95R000110 AU00111 VE95R000111 AU00113 VE95R000113 AU00117 VE95R000117 AU00118 VE95R000118 AU00120 VE95000120 AU00121…
Every code shown here, 1,995 characters
Mfg. Lot or Serial # System ID 1 VE95R00100 AU00104 VE95R00104 AU00107 VE95R00107 AU00109 VE95R000109 AU00110 VE95R000110 AU00111 VE95R000111 AU00113 VE95R000113 AU00117 VE95R000117 AU00118 VE95R000118 AU00120 VE95000120 AU00121 VE95R000121 AU00123 VE95R000123 AU00124 VE95R000124 AU00125 VE95R000125 AU00126 VE90000126 AU00127 VE95R000127 AU00128 VE95R000128 AU00132 VE90000132 AU00133 VE95R000133 AU00135 VE90000135 AU00138 VE95R000138 AU00159 VE95R000159 AU00160 VE9500160 AU00162 VE95000162 AU00165 VE95000165 AU00168 VE95000168 AU00171 VE90000171 AU00172 VE95R000172 AU00173 VE90000173 AU00174 VE90000174 AU00176 VE95000176 AU00182 VE95000182 AU00183 VE90000183 AU00184 VE95R000184 AU00206 VE9500206 AU00207 VE95U00207 AU00211 VE9500211 AU00224 VE90000224 AU00230 VE95000230 AU00231 VE90000231 AU00232 VE90000232 AU00240 VE95R000240 AU00242 VE95000242 AU00243 VE90000243 AU00246 VE95V000246 AU00258 VE90000258 AU00277 VE95R000277 AU00281 VE95000281 AU00287 VE95000287 AU00300 VE95000300 AU00302 VE95R000302 AU00321 VE9500321 AU00329 VE95000329 AU00330 VE95000330 AU00331 VE9500331 AU00332 VE95000332 AU00335 VE95R000335 AU00339 VE9500339 AU00347 VE95000347 AU00348 VE95000348 AU00352 VE95000352 AU00359 VE9500359 AU00360 VE95000360 AU00361 VE95000361 AU00363 VE95000363 AU00367 VE95000367 AU00368 VE95000368 AU00369 VE95000369 AU00370 VE95000370 AU00372 VE95000372 AU00373 VE95000373 AU00374 VE9500374 AU00376 VE95R00376 AU00388 VE95000388 AU00396 VE95000396 AU00398 VE95000398 AU00401 VE95000401 AU00407 VE95R000407 AU00417 VE95000417 AU00426 VE95000426 AU00429 VE95000429 AU00430 VE95000430 AU00434 VE95000434 AU00438 VE9500438 AU00439 VE95000439 AU00441 VE95000441 AU00446 VE90000446 AU00448 VE95000448 AU00450 VE9500450 AU00454 VE95000454 AU00457 VE95000457 AU00460 VE95000460 AU00465 VE95000465 AU00466 VE95000466 AU00468 VE95000468 AU00474 VE95000474 AU00478 VE95000478 AU00482 VE95000482 AU00486 VE95000486 AU00488 VE90000488 AU00494 VE95000494 AU00499 VE95000499 AU00501 VE90000501…
FDA’s list runs to 18,305 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.
United Kingdom, United Arab Emirates, Turkey, Thailand, Switzerland, Sweden, Spain, South Africa, Slovenia, Saudi Arabia, Russia, Romania, Portugal, Poland, Philippines, Norway, New Zealand, New Caledonia, Netherlands, Myanmar, Kuwait, Korea (Republic of), Japan, Italy, ISRAEL, Ireland, Iran, India, Hungary, Hong Kong, Guatemala, Greece, Great Britain, Germany, France, Finland, Estonia, Egypt, Ecuador, Denmark, Czech Republic, Croatia, Colombia, Chile, Canada, Bulgaria, Brunei Darussalam, Brazil, Belgium, Austria, Australia, Argentina, Vietnam. Uruguay, Taiwan, Slovakia, Singapore, Reunion, Qatar, Panama, Pakistan, Jordan, Indonesia, Guadeloupe, Czech Republic
These words name no state.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 10, 2017.
- FDA classified it on Apr 11, 2017.
- FDA’s Enforcement Report published it on Apr 19, 2017.
- FDA terminated it on Mar 12, 2018.
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 18,305 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.