Class 2 Device Recall Philips Telemetry Monitor 5500 1.4 GHz.

• Date Initiated by Firm: June 05, 2026
• Date Posted: June 24, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2579-2026
• Recall Event ID: 99126
• 510(K)Number: K242962
• Product Classification: Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
• 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.
• Code Information: 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.
• FEI Number: 3016618143
• Recalling Firm/ Manufacturer: Philips North America Llc; 222 Jacobs St; Cambridge MA 02141-2289
• For Additional Information Contact: Philips Customer Services; 800-722-9377
• Manufacturer 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.
• FDA Determined Cause: Software design
• Action: Philips Medical notified consignees on about 06/05/2026 via "URGENT Medical Device Correction" letter. Consignees were notified of the issue and potential hazard and instructed to continue the use of the device but avoid touching the display while the device is booting up and provide this notification to all personnel who need to be aware within each organization or to any organization where affected product(s) have been potentially transferred. Philips will release new software which will correct this problem. A Philips representative will contact you to arrange for an upgrade to the new software.
• Quantity in Commerce: 909 units
• Distribution: US Nationwide distribution in the states of AZ, CA, CO, IN, MA, MI, MN, PA, SD, TN.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MHX