Z-2579-2026Class II

Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions...

Name: Z-2579-2026 Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions...
Creator: Philips North America Llc
Published: 2026-06-05
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2026-06-05 / Open, Classified / root cause: software

FDA source

Philips North America Llc began a recall of 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... on 2026-06-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2579-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-05
Posted: 2026-06-24
Recalling firm: Philips North America LLC
Product: 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.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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.
Root cause tag: software
FDA 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 software.
Quantity in commerce: 909 units
Distribution: US Nationwide distribution in the states of AZ, CA, CO, IN, MA, MI, MN, PA, SD, TN.
Product codes and lots: Model Number: 867232. UDI-DI: (01)00884838102842. Software Version Number: 4.0.0.0. Serial Numbers: US001A002F, US001A00AW, US001A00C9, US001A00EW, US001A00F0, US001A00GM, US001A00N4, US001A00PB, US001A00PZ, US001A00R1, US001A00UE, US001A00VU, US001A00Z4, US001A013T, US001A018A, US001A018R.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2579-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2579-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-24

Product code MHX

K242962Class IITelemetry Monitor 5500 Release 4.0 (867232)Philips Medizin Systeme Böblingen GmbH / cleared 2025-05-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)