Reported Jul 31, 2019 · Terminated

MAC VU360, Model Number 2030360-001, Electrocardiograph

GE Healthcare, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615

Is this the product you have?

    • MAC VU360
    • Model Number 2030360-001
    • Electrocardiograph
Lot codes and dates
  • UDI # Serial #

    738 of 738 codes

    • 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
Amount recalled
369 units

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 13, 2021 · Data as of Sep 19, 5:36 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.