MAC VU360, Model Number 2030360-001, Electrocardiograph
Medical device recall Z-2060-2019. Published in FDA’s Enforcement Report on Jul 31, 2019.
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 Jul 31, 2019. 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
- 369 units 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?
Two issues: 1) The MAC VU360 system may intermittently display an incorrect patient ID or visit number on the screen after scanning the patient s barcode. This may result in the ECG report being assigned to the incorrect patient. 2) The MAC VU360 may have the incorrect patient demographics appear on the patient banner. This may result in the ECG report being assigned to the incorrect patient.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
MAC VU360, Model Number 2030360-001, Electrocardiograph
369 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI # Serial # 840682125499VU218440023SA VU218440023SA 840682125499VU218440030SA VU218440030SA 840682125499VU218450037SA VU218450037SA 840682125499VU218450041SA VU218450041SA 840682125499VU218450042SA VU218450042SA…
Every code shown here, 1,975 characters
UDI # Serial # 840682125499VU218440023SA VU218440023SA 840682125499VU218440030SA VU218440030SA 840682125499VU218450037SA VU218450037SA 840682125499VU218450041SA VU218450041SA 840682125499VU218450042SA VU218450042SA 840682125499VU219170004SA VU219170004SA 840682125499VU219130019SA VU219130019SA 840682125499VU219130032SA VU219130032SA 840682125499VU219130039SA VU219130039SA 840682125499VU219130044SA VU219130044SA 840682125499VU219120048SA VU219120048SA 840682125499VU219120052SA VU219120052SA 840682125499VU219120060SA VU219120060SA 840682125499VU219140016SA VU219140016SA 840682125499VU218440018SA VU218440018SA 840682125499VU219140001SA VU219140001SA 840682125499VU219140005SA VU219140005SA 840682125499VU219120044SA VU219120044SA 840682125499VU219120049SA VU219120049SA 840682125499VU219120054SA VU219120054SA 840682125499VU219120055SA VU219120055SA 840682125499VU219120056SA VU219120056SA 840682125499VU219120012SA VU219120012SA 840682125499VU219120014SA VU219120014SA 840682125499VU219120016SA VU219120016SA 840682125499VU219120018SA VU219120018SA 840682125499VU219190012SA VU219190012SA 840682125499VU219130043SA VU219130043SA 840682125499VU218430051SA VU218430051SA 840682125499VU218430052SA VU218430052SA 840682125499VU218430056SA VU218430056SA 840682125499VU218440007SA VU218440007SA 840682125499VU218440010SA VU218440010SA 840682125499VU218450029SA VU218450029SA 840682125499VU218500017SA VU218500017SA 840682125499VU219040005SA VU219040005SA 840682125499VU219040006SA VU219040006SA 840682125499VU218430014SA VU218430014SA 840682125499VU218430058SA VU218430058SA 840682125499VU218430053SA VU218430053SA 840682125499VU218440026SA VU218440026SA 840682125499VU219140036SA VU219140036SA 840682125499VU219170001SA VU219170001SA 840682125499VU219170002SA VU219170002SA 840682125499VU219170009SA VU219170009SA 840682125499VU219130028SA VU219130028SA 840682125499VU219130035SA VU219130035SA 840682125499VU219130042SA VU219130042SA 840682125499VU219140044SA VU219140044SA…
FDA’s list runs to 14,774 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
These words name no state.
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 Jun 28, 2019.
- FDA classified it on Jul 23, 2019.
- FDA’s Enforcement Report published it on Jul 31, 2019.
- FDA terminated it on Apr 13, 2021.
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 14,774 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.