Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue…
Medical device recall Z-1556-2025. 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 systems 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 Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system (Model Numbers H45335VFS, H45335VFSW), R3 Surgery for China, R3 PeriOP for China, R3 Expert for China, R3 Pro for China, R3 Performance for China, R3 Intervention for China diagnostic ultrasound systems
12,808 total systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: Venue Fit R3 system (GTIN 00195278194275 / GTIN 00195278361400); Venue Fit R4 system (GTIN 00195278516497 / GTIN 00195278516503); Venue Fit R3 Surgery for China (GTIN 00195278552488); Venue Fit R3 PeriOP for China (GTIN…
Every code shown here, 1,997 characters
UDI-DI: Venue Fit R3 system (GTIN 00195278194275 / GTIN 00195278361400); Venue Fit R4 system (GTIN 00195278516497 / GTIN 00195278516503); Venue Fit R3 Surgery for China (GTIN 00195278552488); Venue Fit R3 PeriOP for China (GTIN 00195278552501); Venue Fit R3 Expert for China (GTIN 00195278552402); Venue Fit R3 Pro for China (GTIN 00195278552419); Venue Fit R3 Performance for China (GTIN 00195278552440); Venue Fit R3 Intervention for China (GTIN 00195278552495); Venue Fit R5 system (GTIN 00195278424938 / GTIN 00195278425041); Serial IDs: VFC001530 VFD000259 RVFD000123 RVFD000429 VFD001037 RVFD000030 RVFD000035 RVFD000523 VFC000864 VFC000873 VFC000877 VFC000881 VFC000364 VFC000638 VFC000640 VFC000490 RVFC000952 RVFD000297 VFD000567LO VFD000632 VFC000297 VFC000865 VFC000871 RVFD000061 RVFD000432 VFC000665 VFC001417 RVFD000036 VFC001289 RVFD000059 VFC000435 VFC000644 VFD000633 VFC001324 VFD000797 VFC001277 VFD000665 VFD000668 VFC000819 VFC000506 VFC000507 VFC000516 VFD000578 RVFD000122 VFC001254 RVFC000164 VFD000295 VFC001205 VFC000470 VFD000522 VFC000111 VFD000334 VFD001053 VFC000614 RVFD000071 RVFD000072 VFD000073 VFC000942 RVFD000947 VFD000985 VFD000534 VFC000527 VFC000251 VFC001225 VFD000250 VFC001535 VFC001535 VFD000883 VFC001323 VFD000781 VFD001081 RVFD000019 VFC001370 VFC001371 RVFD000067 RVFC001427 VFD000184 VFC000349 VFC001538 VFC001542 VFC001519 VFC000981 VFC000985 VFC000511 VFC000515 VFC001647 VFC001143 VFD000150 VFD000614 VFD000646 VFD000647 VFD000622 VFC000351 VFC000332 RVFD000933 VFC000641 VFC000551 VFD000514 RVFC000166 VFC000993 VFD000205 VFD000579 VFD000580 VFD000585 VFD000586 VFD000546 RVFC000169 VFC000312 VFD000208 VFC000360 VFD000210 VFD000163 VFD000011 VFD000039 VFD000040 VFD000041 VFD000042 VFD000044 VFD000045 VFD000046 VFD000047 VFD000048 VFD000049 VFD000050 VFD000052 VFD000879 VFC000368 VFC000899 VFD000710 VFC001263 RVFD000688 VFC000667 VFC000669 VFD000849 VFD000850 VFC001229 VFD000214 VFD000962 VFC000786 VFC000493 VFC000497 VFC000497 VFC000497…
FDA’s list runs to 35,844 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 35,844 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.