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
The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images...
Medical Devices·330 affected·Mar 29, 2022
High RiskFDA
Philips North America Llc
DigitalDiagnost C50 1.1
Diagnostic Devices·11 affected·Feb 25, 2022
High RiskFDA
Philips North America Llc
Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. For visualization and analysis of pati...
Medical Devices·77 affected·Feb 22, 2022
High RiskFDA
Philips North America, Llc
The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following product model #s: 2107...
Medical Devices·478,931 affected·Feb 7, 2022
High RiskFDA
Philips North America Llc
Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS
Cardiac Devices·1,696,047 affected·Feb 4, 2022
High RiskFDA
Philips North America Llc
Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg, CE 0123, NON-STER...
Cardiac Devices·331,712 affected·Feb 4, 2022
High RiskFDA
Philips North America Llc
Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, ...
Medical Implants·338 affected·Feb 2, 2022
High RiskFDA
Philips North America Llc
eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5....
Medical Devices·36 affected·Jan 3, 2022
High RiskFDA
Philips North America Llc
Medichoice Infant Heel Warmer, Reference # 989805643721 1079906
Medical Devices·2,925,800 affected·Nov 29, 2021
High RiskFDA
Philips North America Llc
Heel Snuggler, Reference # 989805603411 99047
Medical Devices·2,509,100 affected·Nov 29, 2021
High RiskFDA
Philips North America Llc
Infant Heel Warmers w/strap, Reference # 989805603201 1223
Medical Devices·5,164,600 affected·Nov 29, 2021
High RiskFDA
Philips North America Llc
Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T
Medical Devices·4,920,600 affected·Nov 29, 2021
High RiskFDA
Philips North America Llc
Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Medical Devices·141,744 affected·Nov 26, 2021
CriticalFDA
Philips North America Llc
Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chiller WITHOUT an ex...
Medical Devices·63 affected·Nov 24, 2021
CriticalFDA
Philips North America Llc
Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an extended drip tray: Model Number: ...
Medical Devices·1 affected·Nov 24, 2021
High RiskFDA
Philips North America Llc
Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applic...
Diagnostic Devices·5 affected·Nov 19, 2021
CriticalFDA
Philips North America Llc
BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075
Diagnostic Devices·22 affected·Nov 12, 2021
High RiskFDA
Philips North America Llc
Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency ...
Medical Devices·10 affected·Nov 12, 2021
CriticalFDA
Philips North America Llc
CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031
Diagnostic Devices·512 affected·Oct 21, 2021
CriticalFDA
Philips North America Llc
ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110
Diagnostic Devices·243 affected·Oct 21, 2021
High RiskFDA
Philips North America Llc
Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 7...
Medical Devices·428 affected·Sep 24, 2021
CriticalFDA
Philips North America Llc
The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications...
Medical Implants·4 affected·Aug 13, 2021
CriticalFDA
Philips North America Llc
The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: "Image guidance in diagnostic, ...
Cardiac Devices·1 affected·Aug 13, 2021
High RiskFDA
Philips North America Llc
Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-se...
Diagnostic Devices·12 affected·Aug 11, 2021
High RiskFDA
Philips North America Llc
SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system...
Diagnostic Devices·198 affected·Aug 11, 2021
High RiskFDA
Philips North America Llc
Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-...
Diagnostic Devices·147 affected·Aug 11, 2021
High RiskFDA
Philips North America Llc
Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sect...
Diagnostic Devices·1,517 affected·Aug 11, 2021
High RiskFDA
Philips North America Llc
Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-se...
Diagnostic Devices·266 affected·Aug 11, 2021
High RiskFDA
Philips North America Llc
Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-...
Diagnostic Devices·228 affected·Aug 11, 2021
High RiskFDA
Philips North America Llc
Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross...
Diagnostic Devices·99 affected·Aug 11, 2021
High RiskFDA
Philips North America Llc
Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce c...
Diagnostic Devices·42 affected·Aug 11, 2021
High RiskFDA
Philips North America Llc
Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-s...
Diagnostic Devices·6 affected·Jul 30, 2021
High RiskFDA
Philips North America Llc
Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectio...
Diagnostic Devices·3 affected·Jul 30, 2021
High RiskFDA
Philips North America Llc
Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectio...
Diagnostic Devices·1 affected·Jul 30, 2021
High RiskFDA
Philips North America Llc
Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cro...
Diagnostic Devices·2 affected·Jul 30, 2021
High RiskFDA
Philips North America Llc
Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectio...
Diagnostic Devices·3 affected·Jul 30, 2021
High RiskFDA
Philips North America Llc
728333 Spectral CT 7500 -Computed Tomography X-ray system
Medical Devices·1 affected·Jun 8, 2021
High RiskFDA
Philips North America Llc
728332 IQon Spectral CT-Computed Tomography X-ray system
Medical Devices·0 affected·Jun 8, 2021
High RiskFDA
Philips North America Llc
728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
Medical Devices·3 affected·Jun 8, 2021
High RiskFDA
Philips North America Llc
728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
Medical Devices·3 affected·Jun 8, 2021
High RiskFDA
Philips North America Llc
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT
Medical Devices·1,301 affected·May 1, 2021
High RiskFDA
Philips North America Llc
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882446 - Vereos PET/CT
Medical Devices·1,301 affected·May 1, 2021
High RiskFDA
Philips North America Llc
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems: Model -...
Medical Devices·1,301 affected·May 1, 2021
High RiskFDA
Philips North America Llc
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64 System Number: 882471 Continuous CT (CCT) is a CT or PE...
Medical Devices·4 affected·May 1, 2021
High RiskFDA
Philips North America Llc
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728333 - Spectral CT:
Medical Devices·1,301 affected·May 1, 2021
High RiskFDA
Philips North America Llc
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brillian...
Medical Devices·1,301 affected·May 1, 2021
High RiskFDA
Philips North America Llc
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GXL 16 Slice System Number: 882410 Continuous CT (CCT) is a...
Medical Devices·1 affected·May 1, 2021
High RiskFDA
Philips North America Llc
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilli...
Medical Devices·1,301 affected·May 1, 2021