GE Healthcare, CardiacVX [CardiacVX
Medical device recall Z-1511-2014. Published in FDA’s Enforcement Report on May 7, 2014.
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 May 7, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Indiana the one state its words name
- 101 (1 US , 100 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 recently become aware of a potential safety issue due to higher than actual flow values reported on CardiacVX and CardiacVX Flow running on Advantage Workstation.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]. Model #’s 5434389-2 and 5434384-2. The GE Cardiac VX for MRI is an analytical software tool, which provides reproducible tools for the review and reporting of medical images.
101 (1 US , 100 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
FMI# 60857 & Descr: CARDIAC VX Mfg Lot or Serial # System ID 00000D13194001 0000AP12171002 00000L0240862D 604682AWW4 00000287171GE3 00000322015GE9 00000287170GE5 506648AW1 00000328735GE6 00000281269GE1 604875AW1 00000LA714FC0A 562225MR2A…
Every code shown here, 1,998 characters
FMI# 60857 & Descr: CARDIAC VX Mfg Lot or Serial # System ID 00000D13194001 0000AP12171002 00000L0240862D 604682AWW4 00000287171GE3 00000322015GE9 00000287170GE5 506648AW1 00000328735GE6 00000281269GE1 604875AW1 00000LA714FC0A 562225MR2A 00000287169GE7 PASSMR1AW 00000Y13168001 M1102608 00000M13099001 RE1046AW01 00000P13074002 M4189445 00000S13081001 M4189445 00000L02687172 M2322216 00000L0240825E M2322233 00000L3A2D12BA M2322241 0000AN12171001 M155485707 0000AP12178001 M40345204 00000R13178002 M178710405 00000T13185001 M2426003 00000L13184001 M1248303 00000H13032001 A4463335 00000N13172001 M4482629 00000L13197001 00000N13030001 I9237520 00000M12341002 0000AN12171002 M2844538 0000AM12178005 C2195283 00000X12340001 C2195282 0000AM12178001 M2322247 00000M12341001 M2322247 0000AP12290001 X59655524 00000B12299001 X59655525 00000N13112001 M2148251 0000AA12213001 M4181459 0000AR12310001 M4166643 0000AD12321001 M9481854 00000R12325001 M9481855 00000M13135001 00000L020E0B14 A54013104 00000L3A3E5D1C A5624137 00000L3A5D9820 A5624137 00000H13071001 A5164528 00000LA71385A1 A5164527 0000AM12178002 A5624134 0000AA13107002 RL6035 00000P13010001 PZ0383 00000T13158001 PM0032 00000L3AB045C6 PM0278 00000X13200001 0000AM12178004 RL6025 00000V13009001 RL6059 0000AM12178003 RL6043 00000G12362001 JW0128 0000AM12178006 PMW087 0000ZA12135001 RL6009 0000AR12310002 RL6123 00000E12356001 PY0207 00000U13057001 RL6092 00000L13014001 RL6111 00000M13024001 RL6071 00000P13004001 RLW118 00000G13038001 RL6088 00000P13074001 RL6096 00000Q13092001 00000H13032002 0850270409AW1 0000AN12171003 0850270411AW1 0000AP12178002 KW1112AW03 0000AN12312001 0920499069 00000328736GE4 00000H13032003 PL1735AW08 00000L3A2CA72F PL1735AW01 00000LA71BD437 600042AW11 00000L3A2D1359 PL1751AW02 00000R12328001 PL2902AW01 00000Q13102001 PL1050AW02 00000N13022001 00000T13043001 SA1051AW03 0000AE13108001 0000AA13113001 00000R13178001 00000Z13190001 0000AF13098001 SA1255AW02 00000R13029001 00000L8B19A930 NP739729 00000V13009002…
FDA’s list runs to 2,343 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 IN and Internationally to AUSTRALIA, CANADA, CHILE, FRANCE, ITALY, JAPAN, KOREA, KUWAIT, NEW ZEALAND, PANAMA, POLAND, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM,
The states and territories these words name
- Indiana
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 Apr 7, 2014.
- FDA classified it on Apr 25, 2014.
- FDA’s Enforcement Report published it on May 7, 2014.
- FDA terminated it on May 29, 2014.
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 2,343 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.