Philips North America, LLC
273 recalls on record · Latest: Dec 10, 2025
FDA Devices Moderate Nov 27, 2019
HeartStart XL+ Defibrillator/Monitor, Model 861290
FDA Devices Moderate Oct 2, 2019
Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758
FDA Devices Moderate Sep 25, 2019
IntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors-The affected product is a 74 foot (22.6m) combined coax and unshielded twisted pai…
FDA Devices Moderate Sep 18, 2019
HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightweight, portable external defibrillator, offering …
FDA Devices Moderate Sep 18, 2019
Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedside monitorin…
FDA Devices Moderate Aug 14, 2019
Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows: Azurion 3 M12, Azurion 3 M15, Azurion 7 …
FDA Devices Moderate Jul 17, 2019
Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6,…
FDA Devices Moderate Jun 12, 2019
IntelliVue MX40 Patient Monitor, Product number 865351, Service Numbers All other countries: 453564451791, 453564451811, 453564467721, 453564467741,…
FDA Devices Moderate May 22, 2019
SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
FDA Devices Moderate May 22, 2019
SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
FDA Devices Moderate May 22, 2019
SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
FDA Devices Moderate May 22, 2019
SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
FDA Devices Moderate May 22, 2019
SureSigns VS4 Government Bundle, Product Number 863286. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
FDA Devices Moderate May 8, 2019
Fetal Spiral Electrode, Model No. 9898 031 37631
FDA Devices Moderate Apr 17, 2019
Azurion FlexArm, 722079
FDA Devices Moderate Apr 3, 2019
MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoro…
FDA Devices Moderate Apr 3, 2019
Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray …
FDA Devices Moderate Apr 3, 2019
MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Product Usage: As a multifunctional I universal imaging application sys…
FDA Devices Moderate Apr 3, 2019
URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system wit…
FDA Devices Moderate Feb 27, 2019
PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric pati…
FDA Devices Moderate Feb 27, 2019
PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric pati…
FDA Devices Critical Feb 14, 2018
MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product Usage: The HeartStart MRx is for use for the termination of v…
FDA Devices Critical Apr 5, 2017