MAC VU360, Model Number 2030360-001, Electrocardiograph
FDA Recall Z-2060-2019 · Posted None
Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeDQK
Date Initiated2019-06-28
Date Terminated2021-04-13
Product Quantity369 units
Reason for Recall
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.
Firm Action
The firm issued an Urgent Medical Device Correction letter on 06/28/2019 to tis consignees by mail. This letter informed the customer of the issues and provides instructions for continued use of the system. GE Healthcare will correct the system by upgrading the software.
Root Cause
Software design
Distribution Pattern
Worldwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.