FDAJune 28, 2019device
MAC VU360, Model Number 2030360-001, Electrocardiograph
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
ge healthcare
Recall history
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