Philips North America, LLC
273 recalls on record · Latest: Dec 10, 2025
FDA Devices Moderate Apr 19, 2023
CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031
FDA Devices Moderate Apr 19, 2023
ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110
FDA Devices Moderate Apr 19, 2023
Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201
FDA Devices Moderate Apr 19, 2023
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
FDA Devices Moderate Dec 14, 2022
Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144
FDA Devices Moderate Dec 14, 2022
Philips MR 7700 System, Model Number 782120
FDA Devices Moderate Oct 12, 2022
MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
FDA Devices Moderate Sep 7, 2022
DigitalDiagnost C50 1.1
FDA Devices Moderate May 18, 2022
Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. For visualization and analysis of patient hemodyna…
FDA Devices Moderate Apr 20, 2022
The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following product model #s: 21075A, 21076A, …
FDA Devices Moderate Apr 13, 2022
Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS
FDA Devices Moderate Apr 13, 2022
Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg, CE 0123, NON-STERILE, Rx only…
FDA Devices Moderate Apr 13, 2022
Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 7220…
FDA Devices Moderate Mar 16, 2022
Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chiller WITHOUT an extended drip …
FDA Devices Moderate Mar 16, 2022
Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an extended drip tray: Model Number: 722031
FDA Devices Moderate Feb 9, 2022
eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5.2, eCareMana…
FDA Devices Moderate Jan 26, 2022
Infa-Therm Transport Mattress, Reference Number 989805616831 1015
FDA Devices Moderate Jan 26, 2022
Medichoice Infant Heel Warmer, Reference # 989805643721 1079906
FDA Devices Moderate Jan 26, 2022
Heel Snuggler, Reference # 989805603411 99047
FDA Devices Moderate Jan 26, 2022
Infant Heel Warmers w/strap, Reference # 989805603201 1223
FDA Devices Moderate Jan 26, 2022
Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T
FDA Devices Moderate Jan 19, 2022
Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recover…
FDA Devices Moderate Dec 29, 2021
Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, incl…
FDA Devices Moderate Dec 15, 2021
BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075
FDA Devices Moderate Dec 1, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64 System Number: 882471 Continuous CT (CCT) is a CT or PET/CT product…
FDA Devices Moderate Dec 1, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GXL 16 Slice System Number: 882410 Continuous CT (CCT) is a CT or PET/C…
FDA Devices Moderate Dec 1, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16 System Number: 882470 Continuous CT (CCT) is a CT or PET/CT produ…
FDA Devices Moderate Dec 1, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select PET/CT System Number: 882438 Continuous CT (CCT) is a CT or P…
FDA Devices Moderate Nov 17, 2021
Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 72222…
FDA Devices Moderate Oct 20, 2021
Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
FDA Devices Moderate Oct 20, 2021
Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304
FDA Devices Moderate Sep 22, 2021
The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including …
FDA Devices Moderate Sep 22, 2021
The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: "Image guidance in diagnostic, intervention…
FDA Devices Moderate Sep 15, 2021
Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional imag…
FDA Devices Moderate Sep 15, 2021
SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce…
FDA Devices Moderate Sep 15, 2021
Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional im…
FDA Devices Moderate Sep 15, 2021
Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images…
FDA Devices Moderate Sep 15, 2021
Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional imag…
FDA Devices Moderate Sep 15, 2021
Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional im…
FDA Devices Moderate Sep 15, 2021
Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional i…
FDA Devices Moderate Sep 15, 2021
Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-section…
FDA Devices Moderate Sep 1, 2021
Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional ima…
FDA Devices Moderate Sep 1, 2021
Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, …
FDA Devices Moderate Sep 1, 2021
Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, …
FDA Devices Moderate Sep 1, 2021
Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional…
FDA Devices Moderate Sep 1, 2021
Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, …
FDA Devices Moderate Aug 25, 2021
728333 Spectral CT 7500 -Computed Tomography X-ray system
FDA Devices Moderate Aug 25, 2021
728332 IQon Spectral CT-Computed Tomography X-ray system
FDA Devices Moderate Aug 25, 2021
728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
FDA Devices Moderate Aug 25, 2021