FDA recall Z-2579-2026

Philips North America Llc · Class II · device

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 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.

Distribution

US Nationwide distribution in the states of AZ, CA, CO, IN, MA, MI, MN, PA, SD, TN.

Key facts

Status
Ongoing
Initiation date
2026-06-05
Report date
2026-07-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cambridge, MA, United States

Primary source

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