Philips North America Llc: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Recall Summary Philips is recalling certain Telemetry Monitor 5500 1.4 GHz patient monitoring devices because they may unexpectedly reset to a default state, causing them to lose their settings and fail to reconnect to the central monitoring system. The affected devices are used in healthcare facilities across the United States to monitor patients for heart rhythm abnormalities. This is a Class II recall, meaning the problem could result in serious injury or death.
- 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.
- Reason
- 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
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-05
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO, IN, MA, MI, MN, PA, SD, TN.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/30e12ac5-f701-4ec2-8046-a170be15b1a9