FDA-Device2026-07-01Class IIPROCESSING DEFECT

Philips Telemetry Monitor 5500 recalled for potential device reset and loss of central monitoring connection

OTHERNationwide distributiondevice

Philips Telemetry Monitor 5500 recalled for reset risk

Philips Telemetry Monitor 5500 (model 867232) devices may unexpectedly reset to a default state, causing them to lose their configuration settings and disconnect from the hospital's central monitoring system. This could prevent the monitor from reconnecting to the PIC iX central system until manually reconfigured.

  • If you operate this device in a hospital or clinical setting, contact Philips North America for instructions on identifying affected units and applying any available fixes or firmware updates.
  • Affected serial numbers are listed in the original FDA notice; check your device's serial number to determine if it is involved.
  • Do not rely on affected monitors without confirming they can reconnect to your central monitoring system.
Hazard

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.

Who it affects
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of AZ, CA, CO, IN, MA, MI, MN, PA, SD, TN.
Affected count
909 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2579-2026

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