Philips North America recalls
Philips North America appears in 563 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System
FDA Device · Class II · 2020-05-13 · Philips North America - Philips Brilliance iCT Computed Tomography X-Ray System
FDA Device · Class II · 2020-05-13 · Philips North America - Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in diagnostic, interventional and minimally invasive surgery p…
FDA Device · Class II · 2020-05-06 · Philips North America - Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography
FDA Device · Class II · 2020-05-06 · Philips North America - Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Interventional fluor…
FDA Device · Class II · 2020-05-06 · Philips North America - Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.00 - P…
FDA Device · Class II · 2020-04-08 · Philips North America - UroDiagnost Eleva, system code 708033
FDA Device · Class II · 2020-03-25 · Philips North America - MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038
FDA Device · Class II · 2020-03-25 · Philips North America - Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)
FDA Device · Class II · 2020-03-25 · Philips North America - HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536…
FDA Device · Class II · 2020-03-25 · Philips North America - Cardio Vascular-Allura Centron, system code 722400
FDA Device · Class II · 2020-03-25 · Philips North America - Integris Allura 9, system codes 722018 722021
FDA Device · Class II · 2020-03-25 · Philips North America - Allura Exper FD Series
FDA Device · Class II · 2020-03-25 · Philips North America - OmniDiagnost Eleva System codes 708028 708027
FDA Device · Class II · 2020-03-25 · Philips North America - Poly G Integris H5000, System code 72246
FDA Device · Class II · 2020-03-25 · Philips North America - Allura CV20, system code 722031
FDA Device · Class II · 2020-03-25 · Philips North America - Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Product Usage: is intend…
FDA Device · Class II · 2020-03-04 · Philips North America - Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is available in four different configurat…
FDA Device · Class II · 2020-03-04 · Philips North America - Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063
FDA Device · Class II · 2020-02-26 · Philips North America - Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
FDA Device · Class II · 2020-02-26 · Philips North America - VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Az…
FDA Device · Class II · 2020-02-19 · Philips North America - HeartStart XL+ Defibrillator/Monitor, Model 861290
FDA Device · Class II · 2019-12-11 · Philips North America - HeartStart XL+ Defibrillator/Monitor, Model 861290
FDA Device · Class II · 2019-11-27 · Philips North America - Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758
FDA Device · Class II · 2019-10-02 · Philips North America - IntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors-The affected product is a 74 foot (22.6m) combined coax and unshielded tw…
FDA Device · Class II · 2019-09-25 · Philips North America - HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightweight, portable external defibrillator,…
FDA Device · Class II · 2019-09-18 · Philips North America - Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedside moni…
FDA Device · Class II · 2019-09-18 · Philips North America - Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows: Azurion 3 M12, Azurion 3 M15, Azur…
FDA Device · Class II · 2019-08-14 · Philips North America - Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5,…
FDA Device · Class II · 2019-07-17 · Philips North America - Philips IntelliBridge System configured with a regional setting which uses a comma for a decimal separator: 866417 IntelliBridge System C.0…
FDA Device · Class III · 2019-06-19 · Philips North America - Philips Patient Information Center iX configured with a regional setting which uses a comma for a decimal separator: 866389 Patient Informa…
FDA Device · Class III · 2019-06-19 · Philips North America - IntelliVue MX40 Patient Monitor, Product number 865352, Service Numbers All: 453564262571, 453564262591, 453564615311, 453564615331, 453564…
FDA Device · Class II · 2019-06-12 · Philips North America - IntelliVue MX40 Patient Monitor, Product number 865351, Service Numbers All other countries: 453564451791, 453564451811, 453564467721, 4535…
FDA Device · Class II · 2019-06-12 · Philips North America - IntelliVue MX40 Patient Monitor, Product number 857146, Service Numbers All: 453564711531 and 453564711541 - Product Usage: Used primarily…
FDA Device · Class II · 2019-06-12 · Philips North America - IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and 453564262511 - Product Usage: Used primarily as a t…
FDA Device · Class II · 2019-06-12 · Philips North America - SureSigns VS3 NBP, SpO2, Product Number 863071
FDA Device · Class II · 2019-05-22 · Philips North America - SureSigns VS3 NBP, SpO2, Rec, Product Number 863072
FDA Device · Class II · 2019-05-22 · Philips North America - SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074
FDA Device · Class II · 2019-05-22 · Philips North America - SureSigns VS4 Government Bundle, Product Number 863286
FDA Device · Class II · 2019-05-22 · Philips North America - SureSigns VS3 NBP, Product Number 863069
FDA Device · Class II · 2019-05-22 · Philips North America - SureSigns VS3 NBP, SpO2, Temp, Product Number 863073
FDA Device · Class II · 2019-05-22 · Philips North America - SureSigns VS3 NBP Temp, Product Number 863070
FDA Device · Class II · 2019-05-22 · Philips North America - SureSigns VS4 NBP, SpO2, Product Number 863283
FDA Device · Class II · 2019-05-22 · Philips North America - Fetal Spiral Electrode, Model No. 9898 031 37631
FDA Device · Class II · 2019-05-08 · Philips North America - Azurion FlexArm, 722079
FDA Device · Class II · 2019-04-17 · Philips North America - Urodiagnost, Product No. 708033 Product Usage: The Philips UroDiagnost MRF can be used to perform all urological and gynecological routine…
FDA Device · Class II · 2019-04-03 · Philips North America - MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Product Usage: As a multifunctional I universal imaging applicat…
FDA Device · Class II · 2019-04-03 · Philips North America - URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray syst…
FDA Device · Class II · 2019-04-03 · Philips North America - Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor REF: 989803176201 - Product Usage: Indicated for use by health car…
FDA Device · Class II · 2019-04-03 · Philips North America - MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a multifunctional I universal imaging application system, General RIF,…
FDA Device · Class II · 2019-04-03 · Philips North America