Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2060-2019 — MAC VU360, Model Number 2030360-001, Electrocardiograph

U.S. FDA — Device Enforcement · United States · 2019-06-28 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2060-2019
Date of alert
2019-06-28
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE Healthcare, LLC
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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