Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD.
Medical device recall Z-1780-2017. 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
- 396 (67 US; 329 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 S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD.
396 (67 US; 329 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 000955S60 VS60000955 000973S70 VS70000973 000974S70 VS7000974 000997S70 VS70000997 001022S70 VS70001022 001020S70 VS70001020 000941S70 VS70000941 000951S70 VS70000951 000982S70 VS70000982 000981S70 VS70000981…
Every code shown here, 1,992 characters
Mfg. Lot or Serial # System ID 000955S60 VS60000955 000973S70 VS70000973 000974S70 VS7000974 000997S70 VS70000997 001022S70 VS70001022 001020S70 VS70001020 000941S70 VS70000941 000951S70 VS70000951 000982S70 VS70000982 000981S70 VS70000981 000994S70 VS70000994 000976S70 VS70R000976 000993S70 VS70000993 000980S70 VS70000980 000998S70 VS70R000998 000996S70 VS70000996 001005S70 VS70001005 001010S70 VS70001010 001007S70 VS70001007 001008S70 VS70001008 001021S70 VS70001021 001029S70 VS70001029 001040S60 VS60001040 001052S70 VS70001052 001048S70 VS70001048 001051S70 VS70001051 001066S60 VS60001066 001054S60 VS60001054 001059S70 VS70001059 001064S70 VS70001064 001067S70 VS70001067 001062S70 VS70001062 001047S70 VS70001047 001050S70 VS70001050 001073S70 VS70001073 001076S70 VS70001076 001078S70 VS70001078 001074S70 VS70001074 001129S70 VS70001129 001120S60 VS6001120 001137S70 VS70001137 001157S70 VS70001157 001230S60 VS60001230 001246S60 VS60001246 001253S60 VS6001253 001336S60 VS6001336 001345S60 VS60001345 000948S70 VS70000948 000995S70 VS70000995 001053S70 VS70001053 001055S60 VS60001055 001056S70 VS70001056 001039S70 VS70001039 001060S70 VS70001060 001069S70 VS70001069 001112S60 VS60001112 001128S70 VS70001128 001138S70 VS70001138 001163S70 VS70001163 001165S70 VS70001165 001238S60 Not Available 001256S60 VS60001256 001003S70 VS70001003 001332S60 VS60001332 001347S60 VS60001347 001329S60 VS60001329 001310S60 Not Available 001250S70 Not Available 000969S70 VS70969S70 000971S70 00123ULT34 000966S70 00111ULT15 001023S70 00111ULT14 001046S70 00982ULT02 001036S70 00506ULT19 001072S70 20347ULT03 001117S60 00058ULT15 001175S70 00115ULT16 001298S70 00149ULT44 001340S70 00004ULT17 001150S70 00199ULT36 001264S70 00199ULT39 001260S70 00199ULT37 001254S70 00199ULT36 000978S70 00459ULT17 001322S70 00624ULT30 001307S70 00136ULT11 001309S70 21367ULT01 001354S60 00195ULT26 001337S70 00296ULT13 001002S70 0853380377 001182S70 529040US21 001325S70 Not Available 001114S70 A004US71…
FDA’s list runs to 8,344 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 8,344 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.