FDA-Device2019-07-31Class II
MAC VU360, Model Number 2030360-001, Electrocardiograph
GE Healthcare, LLC
Hazard
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.
Sold states
Worldwide
Affected count
369 units
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
MAC VU360, Model Number 2030360-001, Electrocardiograph
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2060-2019Don't want to check this manually?
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