GE Healthcare, LLC recalls MAC VU360, Model Number 2030360-001, Electrocardiograph

Recall date

June 28, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2060-2019

FDA classification

Class II

Brand / firm

GE Healthcare, LLC

Sold / distributed

Worldwide

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MAC VU360, Model Number 2030360-001, Electrocardiograph