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 VU360Model Number 2030360-001Electrocardiograph
- Lot codes and dates
- UDI # Serial #
738 of 738 codes
840682125499VU218440023SAVU218440023SA840682125499VU218440030SAVU218440030SA840682125499VU218450037SAVU218450037SA840682125499VU218450041SAVU218450041SA840682125499VU218450042SAVU218450042SA840682125499VU219170004SAVU219170004SA840682125499VU219130019SAVU219130019SA840682125499VU219130032SAVU219130032SA840682125499VU219130039SAVU219130039SA840682125499VU219130044SAVU219130044SA840682125499VU219120048SAVU219120048SA840682125499VU219120052SAVU219120052SA840682125499VU219120060SAVU219120060SA840682125499VU219140016SAVU219140016SA840682125499VU218440018SAVU218440018SA840682125499VU219140001SAVU219140001SA840682125499VU219140005SAVU219140005SA840682125499VU219120044SAVU219120044SA840682125499VU219120049SAVU219120049SA840682125499VU219120054SAVU219120054SA840682125499VU219120055SAVU219120055SA840682125499VU219120056SAVU219120056SA840682125499VU219120012SAVU219120012SA840682125499VU219120014SAVU219120014SA840682125499VU219120016SAVU219120016SA840682125499VU219120018SAVU219120018SA840682125499VU219190012SAVU219190012SA840682125499VU219130043SAVU219130043SA840682125499VU218430051SAVU218430051SA840682125499VU218430052SAVU218430052SA
- UDI # Serial #
- 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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