GE Healthcare Muse v7 cardiology information system
Medical device recall Z-1133-2013. Published in FDA’s Enforcement Report on Apr 24, 2013.
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 24, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- US Virgin Islands the one state its words name
- 963 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 conducted a recall on the Muse v7 because incorrect medications were displayed on the MUSE, which could result in incorrect treatment.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare Muse v7 cardiology information system. Model number 2026443-001: MUSE 7.0 app cd, Model Number 2026443-015: MUSE 7.0.2 app cd, Model number 2026443-017: MUSE 7.1 app cd, Model number 2026443-029:MUSE 7.1.1 A app cd, and Model Number 2026443-031: MUSE 7.1.1 app cd. Intended to store, access and manage cardiovascular information on adult and pediatrics patients.
963, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Number SBP05450003GA SBP05450009GA SBP05500067GA SBP06100195GA SBP06110200GA SBP06110203GA SBP06160274GA SBP06170288GA SBP06180296GA SBP06180306GA SBP06180308GA SBP06190316GA SBP06190326GA SBP06190329GA SBP06190330GA SBP06200371GA…
Every code shown here, 1,988 characters
Serial Number SBP05450003GA SBP05450009GA SBP05500067GA SBP06100195GA SBP06110200GA SBP06110203GA SBP06160274GA SBP06170288GA SBP06180296GA SBP06180306GA SBP06180308GA SBP06190316GA SBP06190326GA SBP06190329GA SBP06190330GA SBP06200371GA SBP06200377GA SBP06230507GA SBP06230512GA SBP06250577GA SBP06260614GA SBP06260619GA SBP06280624GA SBP06280626GA SBP06280629GA SBP06280637GA SBP06280653GA SBP06290744GA SBP06290748GA SBP06290758GA SBP06290768GA SBP06300778GA SBP06300789GA SBP06310812GA SBP06310814GA SBP06330820GA SBP06330824GA SBP06330838GA SBP06330841GA SBP06330853GA SBP06330873GA SBP06330878GA SBP06340958GA SBP06340959GA SBP06360974GA SBP06360979GA SBP06360983GA SBP06361019GA SBP06371040GA SBP06371055GA SBP06371058GA SBP06371061GA SBP06391095GA SBP06391100GA SBP06411137GA SBP06411147GA SBP06421164GA SBP06421167GA SBP06421169GA SBP06421171GA SBP06421183GA SBP06421189GA SBP06431228GA SBP06441246GA SBP06441251GA SBP06441277GA SBP06441279GA SBP06441282GA SBP06441296GA SBP06441306GA SBP06441312GA SBP06441319GA SBP06451321GA SBP06451335GA SBP06451337GA SBP06451340GA SBP06481394GA SBP06481398GA SBP06481421GA SBP06491463GA SBP06491466GA SBP06491469GA SBP06491472GA SBP06501503GA SBP06501507GA SBP06511545GA SBP06511569GA SBP06511571GA SBP06511579GA SBP06511615GA SBP06511621GA SBP06521635GA SBP06521648GA SBP06521689GA SBP06521693GA SBP06521694GA SBP06521708GA SBP06521710GA SBP06521711GA SBP07021747GA SBP07021755GA SBP07041777GA SBP07041783GA SBP07041791GA SBP07051813GA SBP07061846GA SBP07061860GA SBP07061871GA SBP07061877GA SBP07061887GA SBP07061892GA SBP07061929GA SBP07071968GA SBP07081995GA SBP07082002GA SBP07092008GA SBP07092009GA SBP07102056GA SBP07122076GA SBP07122079GA SBP07122131GA SBP07122134GA SBP07122137GA SBP07122144GA SBP07122148GA SBP07132155GA SBP07142179GA SBP07142194GA SBP07142196GA SBP07142197GA SBP07152207GA SBP07152209GA SBP07152212GA SBP07152226GA SBP07152230GA SBP07152233GA SBP07152238GA SBP07162252GA SBP07182285GA SBP07182291GA SBP07182294GA…
FDA’s list runs to 13,481 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 Distribution -- USA, including all states except ME, and the U.S. Virgin Islands; and, the countries of AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHILE, CHINA, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, MALAYSIA, NETHERLAND, NEW ZEALAND, NORWAY, PHILIPPINES,S QATAR, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
The states and territories these words name
- US Virgin Islands
They leave out Maine.
The words say it went outside the United States too.
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 Jan 4, 2012.
- FDA classified it on Apr 17, 2013.
- FDA’s Enforcement Report published it on Apr 24, 2013.
- FDA terminated it on Jul 19, 2013.
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: Visit.
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 13,481 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.