Brand

Philips North America, Llc Recalls

260 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Philips North America, Llc.

260Total Recalls
34Critical
46.6MUnits Affected
Jan 7, 2026Most Recent
All Recalls

Every Philips North America, Llc Recall

Sorted by most recent. Click any recall for full details.

260 recalls
High RiskFDA
Philips North America, Llc
Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedsi...
Medical Devices·280 affected·Jul 19, 2019
High RiskFDA
Philips North America, Llc
Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows: Azurion 3 M12, Azurion 3 M15...
Cardiac Devices·834 affected·Jul 16, 2019
High RiskFDA
Philips North America, Llc
HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightweight, portable external defibrillato...
Cardiac Devices·2 affected·Jul 16, 2019
High RiskFDA
Philips North America, Llc
Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536...
Cardiac Devices·97,794 affected·Jun 7, 2019
High RiskFDA
Philips North America, Llc
SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Medical Devices·518 affected·Apr 19, 2019
High RiskFDA
Philips North America, Llc
SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Medical Devices·21,857 affected·Apr 19, 2019
High RiskFDA
Philips North America, Llc
SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperat...
Medical Devices·12,719 affected·Apr 19, 2019
High RiskFDA
Philips North America, Llc
SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Medical Devices·12,543 affected·Apr 19, 2019
High RiskFDA
Philips North America, Llc
IntelliVue MX40 Patient Monitor, Product number 865351, Service Numbers All other countries: 453564451791, 453564451811, 453564467721, 4...
Medical Devices·0 affected·Mar 28, 2019
High RiskFDA
Philips North America, Llc
Azurion FlexArm, 722079
Medical Devices·2 affected·Mar 12, 2019
High RiskFDA
Philips North America, Llc
MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a multifunctional I universal imaging application system, General...
Medical Implants·1,969 affected·Feb 28, 2019
High RiskFDA
Philips North America, Llc
Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 Product Usage: The Philips OmniDiagnost is a multi-functional, univ...
Diagnostic Devices·1,696 affected·Feb 28, 2019
High RiskFDA
Philips North America, Llc
MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Product Usage: As a multifunctional I universal imaging app...
Medical Implants·1,969 affected·Feb 28, 2019
High RiskFDA
Philips North America, Llc
URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ra...
Diagnostic Devices·1,969 affected·Feb 28, 2019
High RiskFDA
Philips North America, Llc
Fetal Spiral Electrode, Model No. 9898 031 37631
Medical Devices·1,971,925 affected·Jan 25, 2019
High RiskFDA
Philips North America, Llc
PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pe...
Medical Devices·15,064 affected·Jan 9, 2019
High RiskFDA
Philips North America, Llc
PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pe...
Medical Devices·11,332 affected·Jan 9, 2019
High RiskFDA
Philips North America Llc
Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758
Cardiac Devices·181,894 affected·Aug 8, 2018
CriticalFDA
Philips North America, Llc
MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product Usage: The HeartStart MRx is for use for the term...
Cardiac Devices·71 affected·Jul 12, 2017
CriticalFDA
Philips North America, Llc
HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3...
Cardiac Devices·97,794 affected·Feb 24, 2017