Recall Z-2060-2019 ยท DQK Computer, Diagnostic, Programmable
GE Healthcare, LLC
MAC VU360, Model Number 2030360-001, Electrocardiograph
| Date | Jun 28, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| 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. |
| Quantity | 369 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173830 | MAC VU360 Resting ECG Analysis System Ge Medical Systems Information Technologies, Inc., Sep 18, 2018 |