Philips North America
126 FDA actions
Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.
Philips North America
Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Numbe
Philips North America
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377.
Philips North America
Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF):
Philips North America
Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782
Philips North America
Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.
Philips North America
Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.
Philips North America
Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 7821
Philips North America
Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105
Philips North America
Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.
Philips North America
Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341.
Philips North America
Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.
Philips North America
Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.
Philips North America
Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 7
Philips North America
Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 7821
Philips North America
Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.
Philips North America
Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782
Philips North America
Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model
Philips North America
Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number
Philips North America
SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.
Philips North America
Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.
Philips North America
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.
Philips North America
Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.
Philips North America
MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.
Philips North America
Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.
Philips North America
Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.
Philips North America
Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.
Philips North America
SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.
Philips North America
Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.
Philips North America
Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1
Philips North America
Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.
Philips North America
Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.
Philips North America
Patient Information Center iX; Software Version Number: 4.5.0
Philips North America
Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
Philips North America
Cardiac Workstation 5000; Model Number: 860439;
Philips North America
Cardiac Workstation 7000; Model Number: 860441;
Philips North America
Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);
Philips North America
SmartPath to dStream for 3.0T Model Number (REF): 782145;
Philips North America
Ingenia 1.5T S Model Number (REF): 781347;
Philips North America
Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;
Philips North America
MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;
Philips North America
Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;
Philips North America
Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;
Philips North America
Upgrade to MR 7700 Model Number (REF): 782130;
Philips North America
Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;
Philips North America
Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);
Philips North America
Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;
Philips North America
SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;
Philips North America
Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;
Philips North America
Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;
Philips North America
Intera 3.0T Quasar Dual Model Number (REF): 781150;
Philips North America
Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
Philips North America
SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;
Philips North America
MR 7700 Model Numbers (REF): (1) 782120, (2) 782153;
Philips North America
Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;
Philips North America
Intera 1.5T Achieva Nova-Dual Product Number: 781173;
Philips North America
Intera 1.5T Explorer/Nova Dual Product Number: 781108;
Philips North America
SmartPath to dStream for 1.5T¿; Product Number: 782146;
Philips North America
Intera 1.5T Achieva IT Nova Product Number: 781175
Philips North America
Intera 1.5T Achieva Nova Product Number: 781172;
Philips North America
Intera Achieva 1.5T Pulsar; Product Number: 781171;
Philips North America
Intera 1.5T Master/Nova Product Number: 781106;
Philips North America
Intera 1.5T Omni/Stellar; Product Number: 781104;
Philips North America
Achieva XR Product Numbers: (1) 781153, (2) 781253;
Philips North America
Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Softw
Philips North America
IntelliVue G7m Anesthesia Gas Module, Product Number 866173
Philips North America
IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500
Philips North America
PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to V4.5.1.41989-Intend
Philips North America
CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X
Philips North America
Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) runni
Philips North America
ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150
Philips North America
ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110
Philips North America
BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791 4
Philips North America
Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732), patient transportation syst
Philips North America
BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 45356074
Philips North America
Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
Philips North America
BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 453560824741 4535608292
Philips North America
Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732), patient transportation syste
Philips North America
Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.
Philips North America
SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.
Philips North America
Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105.
Philips North America
Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.
Philips North America
Achieva XR. Model (REF) Numbers 781153, 781253.
Philips North America
Achieva 1.5T Initial system. Model (REF) Numbers 781178.
Philips North America
Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345.
Philips North America
Ingenia 1.5T CX. Model (REF) Numbers 781262, 781261.
Philips North America
Intera Achieva 1.5T Pulsar. Model (REF) Number 781171.
Philips North America
Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283.
Philips North America
Intera 1.5T Achieva Nova-Dual. Model (REF) Number 781173.
Philips North America
SmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112.
Philips North America
Achieva 3.0T, Model No. 781177
Philips North America
SmartPath to dStream for 1.5T, Model No. 781260, 782112
Philips North America
Intera 1.5T, Model No. 781195
Philips North America
Achieva 1.5T, Model No. 781178, 781196, 781296
Philips North America
Achieva 1.5T Conversion, Model No. 781283
Philips North America
Ingenia Ambition X, Model No. 782109
Philips North America
Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871
Philips North America
(1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model No. 866390 (3) PIC
Philips North America
(1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436
Philips North America
BrightView X, Gamma Camera, Product Code 882478
Philips North America
(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)
Philips North America
BrightView, Gamma Camera System, Product Code 882480.
Philips North America
BrightView XCT, Gamma Camera, Product Code 882482
Philips North America
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Philips North America
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Philips North America
Allura Xper IGTS Fixed Systems
Philips North America
BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems.
Philips North America
Veradius Unity Mobile Surgery C-arm
Philips North America
Zenition 50 & 70 Mobile Surgery C-arm
Philips North America
Azurion IGTS Fixed Systems
Philips North America
Integris-Allura IGTS Fixed Systems
Philips North America
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Eliti
Philips North America
MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
Philips North America
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Eliti
Philips North America
MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
Philips North America
Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
Philips North America
Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
Philips North America
Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146
Philips North America
Incisive CT-Computed Tomography X-Ray System Model: 728143
Philips North America
Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148
Philips North America
Incisive CT Plus-Computed Tomography X-Ray System Model: 728149
Philips North America
ProxiDiagnost N90 R.1.0
Philips North America
CombiDiagnost R90 R.1.0
Philips North America
CombiDiagnost R90 R1.1
Philips North America
Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813
Philips North America
Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814
Philips North America