Food, drugs, devices › Philips North America Llc
Device recall: Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5
Philips North America Llc (Cambridge, MA) initiated this device recall on 5 Jun 2026; FDA lists 1 product record under event 99126, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Philips North America Llc has 129 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Philips North America Llc, Cambridge, MA.
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2579-2026 | 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. | 909 units | Class II | Ongoing | 1 Jul 2026 |
Context
Other enforcement events for Philips North America Llc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 7 Aug 2026 | Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: | Device | Class II | 4 |
| 1 Jul 2026 | Cardiac Workstation 5000. Product Number: 860439. | Device | Class II | 2 |
| 26 May 2026 | Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A | Device | Class II | 2 |
| 1 May 2026 | DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035. | Device | Class II | 1 |
| 7 Jan 2026 | Brilliance iCT; Product Code (REF): 728306; | Device | Class II | 4 |
| 12 Dec 2025 | Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor. | Device | Class II | 1 |
| 31 Oct 2025 | IntelliVue MP2. Product Number: M8102A. | Device | Class II | 22 |
| 29 Oct 2025 | Incisive CT; Software Version Number: 4.5, 5.0, 5.1; | Device | Class II | 2 |
| 13 Aug 2025 | Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Chan | Device | Class II | 10 |
| 29 May 2025 | Spectral CT. Computed tomography X-ray system. | Device | Class II | 1 |
All 129 events for Philips North America Llc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the states of AZ, CA, CO, IN, MA, MI, MN, PA, SD, TN."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.