Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5…
Medical device recall Z-1555-2025. Published in FDA’s Enforcement Report on Apr 23, 2025.
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 23, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 12,808 total 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?
The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H45135VG, H45135VGW), R3 Surgery for China (Model Number H45113VGSU), R3 PeriOP for China (Model Number H45113VGPO), R3 Expert for China (Model Number H45113VGEX ), R3 Pro for China (Model Number H45113VGPR), R3 Performance for China, R3 Intervention for China, R3 Surgery for China (Model Number H45113VGSU) diagnostic ultrasound systems
12,808 total devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: Venue Go R2 system (GTIN 00840682138840); Venue Go R3 system (GTIN 00840682190503 / GTIN 00195278358011); Venue Go R4 system (GTIN 00195278516510 / GTIN 00195278516527); Venue Go R3 Surgery for China (GTIN 00195278547866) Venue Go…
Every code shown here, 1,996 characters
UDI-DI: Venue Go R2 system (GTIN 00840682138840); Venue Go R3 system (GTIN 00840682190503 / GTIN 00195278358011); Venue Go R4 system (GTIN 00195278516510 / GTIN 00195278516527); Venue Go R3 Surgery for China (GTIN 00195278547866) Venue Go R3 PeriOP for China (GTIN 00195278548344) Venue Go R3 Expert for China (GTIN 00195278547262) Venue Go R3 Pro for China (GTIN 00195278547828) Venue Go R3 Performance for China (GTIN 00195278547842) Venue Go R3 Intervention for China (GTIN 00195278548061) Venue Go R5 system (GTIN 00195278450319 / GTIN 00195278451774); System ID: VENGO000382 VGB002128 VGB003021 VGD000325 VGD002313 VGD000452 VGD000488 VGD002390 VGC006411 VGB002040 VGD000354 VGC000685 VGD001444 VGC006698 VGC007776 RVGC000034 RVGC000035 VGD002256 VGD002533 VGD002535 VGD002536 VGB001162 VGC007292 VGC007119 VGC006083 VGC006841 VGB001011 VGC000147 VGD001510 RVGC000559 RVGC000562 VGD000044 VGD001371 VGD001372 VGD001375 VGD001374 VGD001373 VGD001625 VGD001638 VGC000526 RVGD002184 VGD002513 VGB002239 VGD001705 VGD002307 VGC000746 VGC004373 VGC004378 VGC006707 RVGC007218 RVGC000591 VGD001899 RVGC004147 VGC004351 VGC007098 VGC007102 VGC007105 RVGC000024 RVGC004165 RVGD001551 RVGB000480 RVGB002675 VGC007113 VGD000091 RVGD001076 RVGB000467 VENGO000545 VGC007350 VGD001731 VGB002526 VGC000227 VGD001964 VGD002225 RVGC000303 RVGB000757 RVGB000797 RVGC000302 RVGC000554 VGC000799 RVGC006372 RVGC006771 VGC007879 VGC007880 VGD000524 RVGB000791 VGD001873 VGD002221 VGD002227 VGD002467 VGD000730 VGD001872 VGC007607 VGC007611 RVGC007204 VGC006763 VGD000731 VGD000843 RVGB000694 VGD000553 VGD000554 VGD000558 VGD001336 VGC000898 VGD000200 VGC006715 VGD002460 VGD002462 VGD002427 RVGB000032 RVGC000594 RVGC000617 VGD001738 VGD001747 RVGC006758 RVGD001055 VGB000796 VGB000901 RVGD001795 VGD001400 VGD001401 VGB002539 VGB002613 VGB001125 VGD001200 VGD001257 VGD001258 VGD001258 VGD001257 VGD001261 VGD001257 VGC000386 RVGD001071 VGD002275 VGD001701 VGD001704 VENGO000317 VGB002122 VGD001687 VGD001884…
FDA’s list runs to 114,522 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 - US Nationwide distribution.
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 6, 2025.
- FDA classified it on Apr 11, 2025.
- FDA’s Enforcement Report published it on Apr 23, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Medical Systems, 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 114,522 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.