Recall Z-2579-2026 · MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips North America Llc
Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GHz FAST EX.
| Date | Jun 24, 2026 (initiated Jun 5, 2026) |
| Status | Open, Classified |
| Reason | Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system. |
| Root cause | Software design |
| Action | Philips Medical notified consignees on about 06/05/2026 via "URGENT Medical Device Correction" letter. Consignees were notified of the issue and potential hazard and instructed to continue the use of the device but avoid touching the display while the device is booting up and provide this notification to all personnel who need to be aware within each organization or to any organization where affected product(s) have been potentially transferred. Philips will release new software which will correct this problem. A Philips representative will contact you to arrange for an upgrade to the new so |
| Quantity | 909 units |
| Distribution | US Nationwide distribution in the states of AZ, CA, CO, IN, MA, MI, MN, PA, SD, TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K242962 | Telemetry Monitor 5500 Release 4.0 (867232) Philips Medizin Systeme Böblingen GmbH, May 5, 2025 |