MUSE 5 Systems
Medical device recall Z-1938-2025. Published in FDA’s Enforcement Report on Jun 18, 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 Jun 18, 2025. Copied from openFDA on Oct 24, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 4,277 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 MUSE Administrator Account active directory or local credential could potentially be used from your local network to log into a GE HealthCare MUSE 5 system and potentially manipulate recorded patient data.
FDA, Device recall enforcement reports. Released Oct 23, 2026. Updated weekly.
Which ones are recalled?
MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system that accesses stores and manages cardiovascular information.
4,277 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 23, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: ABF04400266FA SAD04390481GA SAD05091885GA SAD05091907GA SAD05091908GA PA2155054 PA2155057 PA2155059 PA2155061 PA2155063 SAD05302639GA SAD05302646GA SAD05322687GA SAD05322723GA SAD05322735GA SAD06524784GA SAD06204075GA…
Every code shown here, 1,994 characters
Serial Numbers: ABF04400266FA SAD04390481GA SAD05091885GA SAD05091907GA SAD05091908GA PA2155054 PA2155057 PA2155059 PA2155061 PA2155063 SAD05302639GA SAD05302646GA SAD05322687GA SAD05322723GA SAD05322735GA SAD06524784GA SAD06204075GA SAD06204076GA SAD06204077GA SAD04380416GA SAD04380427GA SAD04430607GA SAD04440716GA SAD04440717GA SAD04440718GA SAD04440719GA SAD05453127GA SAD05453128GA SAD05453129GA SAD05453130GA SAD05453172GA SAD08105319GA SAD08105320GA SAD04501236GA SAD04501237GA SAD04501252GA SAD04501257GA SAD04501258GA SAD04350305GA SAD04350317GA SAD04350318GA SAD04350319GA SAD04350320GA SAD04350326GA SAD06424592GA SAD06444630GA SAD06454662GA SAD04491128GA SAD04491129GA SAD04491130GA SAD04491131GA SAD04491132GA SAD04491151GA SAD04501216GA SAD04501217GA SAD04501218GA SAD04501220GA SAD04501221GA SAD04501222GA SAD04501223GA SAD04501224GA SAD04501225GA SAD04501226GA SAD04501227GA SAD04501228GA SAD04501229GA PA2020935 PA2020936 SAD05081763GA SAD05081836GA SAD05091867GA SAD05091868GA SAD0932 SAD09335621GA SAD09335622GA SAD05302635GA SAD06344526GA SAD05091896GA SAD05091905GA SAD05091906GA SAD06424610GA SAD06444638GA SAD06194039GA SAD06194040GA SAD06194041GA SAD05172239GA SAD05172240GA SAD05172241GA SAD05172242GA SAD05172243GA SAD05172268GA SAD05172269GA SAD05172271GA SAD06204073GA SAD05382932GA SAD05392967GA SAD07455199GA SAD08285434GA SAD06113777GA SAD06113778GA SAD06113779GA SAD06113780GA PA2297273 SAD07205030GA SAD07205031GA SAD07215068GA SAD07215069GA SAD05302649GA SAD05322725GA SAD05332753GA SAD05352769GA SAD05473247GA SAD06023533GA SAD06023574GA SAD06474699GA SAD05513429GA SAD05513433GA SAD05513435GA SAD05513436GA SAD05523459GA SAD08355476GA SAD05021340GA SAD05021369GA SAD05021370GA SAD05021371GA SAD05352768GA SAD05352770GA SAD05352776GA SAD05352777GA SAD05503390GA SAD05503394GA SAD05503395GA SAD05523447GA SAD05523448GA SAD05523449GA SAD06033597GA SAD06033598GA SAD06033599GA SAD06033600GA SAD06033601GA SAD04491155GA SAD04491156GA SAD04491157GA SAD06444629GA…
FDA’s list runs to 59,289 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 Apr 25, 2025.
- FDA classified it on Jun 10, 2025.
- FDA’s Enforcement Report published it on Jun 18, 2025.
FDA, Device recall enforcement reports. Released Oct 23, 2026. Updated weekly.
Who is recalling it?
- GE Medical Systems Information Technologies Inc, of Milwaukee, 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 23, 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 59,289 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 23, 2026 and checked Oct 23, 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 24, 2026.