Recall Z-2696-2020 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips North America, LLC
IntelliVue MX800 patient monitor, model no. 865240
| Date | Jun 30, 2020 |
| Status | Terminated |
| Reason | Some Intellivue MX700/MX800 Patient Monitors were delivered with defective power supplies. The defective power supplies might energize the metal parts of monitor if the grounding instructions were not followed, and may also cause the monitor to stop operating or prevent it from being switched on. |
| Root cause | Process control |
| Action | On June 30, 2020, the firm sent Urgent Medical Device Correction letters to affected customers. Customers were instructed to always ensure that the monitor is grounded during operation with mains power. Affected products should be removed from use until the power supply of the monitor has been replaced. Philips Customer Service will contact customers when a replacement power supply is ready for installation. Philips expects all replacements to be complete within six months. If you need any further information or support concerning this issue, please contact your local Philips representative o |
| Quantity | 28 |
| Distribution | Domestic distribution to CA, HI, MA, NY, and UT. International distribution to Costa Rica, Ireland, Lebanon, and Poland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150310 | IntelliVue Patient Monitor Philips Medizin Systeme Boeblingen GmbH, May 13, 2015 |