Home / Recalls / Medical Devices
GE Healthcare, LLC recalls MAC VU360, Model Number 2030360-001, Electrocardiograph
Recalled July 31, 2019 · FDA recall Z-2060-2019 · GE Healthcare
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. · FDA Class II
Units
369 units
Sold at
Worldwide
Description
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.
Product
MAC VU360, Model Number 2030360-001, Electrocardiograph
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →