← FDA ENFORCEMENT
Z-2579-2026Class II

Philips North America Llc

Recalling firm
Philips North America Llc
Product type
Device
Status
Ongoing
Report date
2026-07-01
Distribution
US Nationwide distribution in the states of AZ, CA, CO, IN, MA, MI, MN, PA, SD, TN.
Firm state
MA
Product quantity
909 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
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.

Product description

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.

Code / lot info

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.

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.