Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5
FDA device recall Z-2579-2026 · posted 2026-06-24 · Open, Classified
Recall details
- Recalling firm
- Philips North America Llc
- Reason for recall
- 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.
- Action taken
- 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 software.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- MHX
- Quantity affected
- 909 units
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO, IN, MA, MI, MN, PA, SD, TN.
- Date initiated
- 2026-06-05
- Date posted
- 2026-06-24
- Location
- Cambridge, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Telemetry Monitor 5500 Release 4.0 (867232) (K242962) | Philips Medizin Systeme Böblingen GmbH | 2025-05-05 |