Recall Z-0543-2021 ยท DPS Electrocardiograph
GE Healthcare, LLC
MAC VU360, Electrocardiograph
| Date | Dec 7, 2020 (initiated Oct 27, 2020) |
| Status | Terminated |
| Reason | Incorrect patient identification and/or patient demographic errors. |
| Root cause | Use error |
| Action | On 10/27/2020 the firm sent a letter to its consignees with the following instructions: You can continue to use your MAC VU360 system: At system setup: -Disable Auto-ECG in System Settings until the software has been upgraded. When performing ECGs: - Ensure the current patient lead wires are disconnected before selecting the Start New Patient workflow in the user interface. - Verify there are live scrolling waveforms on the screen before acquiring an ECG on the patient. - Verify the date and time of the ECG report corresponds to the patient for whom you are acquiring the ECG. - Always enter |
| Quantity | 5,284 units |
| Distribution | Domestic Distribution: AL,AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI,MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. International Distribution: AUSTRALIA, AUSTRIA, BELGIUM, Canada, CZECH REPUBL |
| 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 |