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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 on

Medical DevicesSource: FDA (device) · Date: 2026-07-01

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
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.
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of AZ, CA, CO, IN, MA, MI, MN, PA, SD, TN.
Recall initiated
2026-06-05
Code 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.
Product quantity
909 units
Voluntary mandated
Voluntary: Firm initiated
City
Cambridge
State
MA
Country
United States
Event id
99126
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