Company: GE Healthcare, LLC
Date of Enforcement Report: 7/31/2019
Class II
PRODUCT
MAC VU360, Model Number 2030360-001, Electrocardiograph
Recall Number: Z-2060-2019
REASON
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.
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC on 6/28/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
369 units
DISTRIBUTION
Worldwide