| 15 Nov 2018 | Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081 | Device | Class II | 1 | Terminated |
| 10 Oct 2018 | IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological… | Device | Class II | 1 | Ongoing |
| 16 Jul 2018 | INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions | Device | Class II | 27 | Terminated |
| 13 Jul 2018 | Philips SureSigns VSV (Vital Signs Viewer), 863067 Indicated for central monitoring of multiple adult, pediatric and neonatal patients, and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric and neonatal patients to gain information for the treatment, to monitor adequacy of treatment, or to… | Device | Class II | 5 | Ongoing |
| 3 May 2018 | HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearable) Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel… | Device | Class II | 1 | Terminated |
| 30 Apr 2018 | IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350 | Device | Class II | 4 | Terminated |
| 16 Mar 2018 | Multiva systems, 1) Multiva 1.5T 8 R5 Model 781072, 2) Multiva 1.5T 16 R5 Model 781073, 3) Multiva 1.5T 8ch R5 based Model 781074, 4) Multiva 1.5T Model 781076, & 5) Multiva 1.5T 16ch R5 based Model 781078 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic… | Device | Class II | 13 | Terminated |
| 14 Mar 2018 | Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system Product Usage: The Allura Xper ED series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic,… | Device | Class II | 1 | Terminated |
| 7 Feb 2018 | HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support, or defibrillation. It must be used by or on the order of a physician. When… | Device | Class III | 1 | Terminated |
| 29 Jan 2018 | Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on HeartStart MRx devices with software version F.01/R.01 or F.02/R.02 installed. The Q-CPR option provides feedback… | Device | Class II | 2 | Terminated |
| 4 Jan 2018 | Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage. Product Usage: The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive… | Device | Class II | 1 | Terminated |
| 3 Jan 2018 | Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0 867141 IntelliVue Info Center iX B.0 866025 IntelliVue Server IX A.0 866118 Database Server Upgrade A.0 | Device | Class II | 1 | Terminated |
| 20 Dec 2017 | Allura Xper FD and and Xper FD ORT - Philips X-ray Systems Product Usage: The Allura Xper FD10 and Alllura Xper FD10/10 is intendd for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and… | Device | Class II | 1 | Terminated |
| 11 Dec 2017 | digital x-ray detector ProGrade R1 - solid state X ray imager (flat panel/digital imager) As a part of a radiographic system, the Philips ProGrade is intended to acquire, process, store, display, and export digital radiographic images. The Philips ProGrade is suitable for all routine radiographic examinations,… | Device | Class II | 1 | Terminated |
| 17 Nov 2017 | IntelliVue X3 Patient Monitor. | Device | Class II | 1 | Terminated |
| 19 Oct 2017 | CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography | Device | Class II | 1 | Terminated |
| 5 Oct 2017 | Philips Network Firewall (Cisco ASA 5506), Model # 867098 | Device | Class II | 1 | Terminated |
| 28 Sep 2017 | Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator | Device | Class II | 1 | Terminated |
| 20 Sep 2017 | Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility. | Device | Class III | 1 | Terminated |
| 23 Aug 2017 | IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient Monitor Models MP2 and MP5 Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended… | Device | Class II | 1 | Ongoing |
| 18 Aug 2017 | Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7 M20 The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes,… | Device | Class II | 1 | Terminated |
| 17 Jul 2017 | ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641. Manufactured - September 4, 2002 October 8, 2014 | Device | Class II | 1 | Terminated |
| 14 Jul 2017 | Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless portable detector free in the room for X-ray exposures. It supports the wireless portable detector with or without a grid. | Device | Class II | 1 | Terminated |
| 31 May 2017 | Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 712210) DuraDiagnost (R2.0, Product Number 712211) DuraDiagnost (R3.0, Product Number 712211) | Device | Class II | 1 | Terminated |
| 11 May 2017 | Philips DigitalDiagnost 3.1.x X-Ray System | Device | Class II | 1 | Terminated |
| 4 May 2017 | NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865383) | Device | Class II | 1 | Terminated |
| 22 Mar 2017 | Allura Xper Release 8.2 (Laird chiller is always installed); Allura Xper FD10 722026; Allura Xper FD10/10 722027; Allura Xper FD20/10 biplane 722029; Allura Xper FD10 OR Table 722033; Allura Xper FD10/10 OR Table 722034; Allura Xper FD20/10 OR Table 722036; Allure Xper FD20/20 722038; Allura Xper FD20/20 biplane OR… | Device | Class II | 3 | Terminated |
| 6 Mar 2017 | Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Exchange part (service numbers): 453564615311 TELE PWM,802.lla/b/g,ECG only, US only 453564615331 TELE PWM,802.1 1 a/b/g,ECG&Sp02, US only Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the… | Device | Class II | 1 | Terminated |
| 18 Jan 2017 | Philips Healthcare Brilliance 64 System, X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. | Device | Class II | 6 | Terminated |
| 17 Jan 2017 | Philips Efficia CMS200 Central Monitoring System; 863352 The Efficia CMS200 central monitoring system is intended for use by healthcare professionals for central viewing of physiologic waves, parameters, and trends from other networked medical devices (patient monitors and vital signs monitors) for multiple patients.… | Device | Class II | 1 | Terminated |
| 27 Dec 2016 | Philips Cisco 3850 layer 3 switch, 865339 model WS-C3850-12S-E in use with IntelliVue Information Center iX or Classic Information Center | Device | Class II | 1 | Terminated |
| 9 Dec 2016 | Velara Generator with an old Firmware version used with Philips Allura Xper Systems (Allura 15 & 12 (monoplane), Allura FD10C, Allura FD10F, Allura FD 10 F/C, Allura FD20, Allura XPER FD10/10, Allura XPER FD20 Biplane) | Device | Class II | 2 | Terminated |
| 1 Dec 2016 | Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP). | Device | Class II | 4 | Terminated |
| 1 Dec 2016 | Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and instructions for proper positioning and MR imaging of those patients. MR-OR option also facilitates execution of simple neurosurgical procedures in the near… | Device | Class II | 1 | Terminated |
| 19 Sep 2016 | Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (1.4GHz) Product Number: 865350 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 USA only SW Revisions: B.05.28, B.05.29, and B.05.32 Indicated for use by health care professionals whenever there is… | Device | Class II | 3 | Terminated |
| 26 Aug 2016 | HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A | Device | Class II | 1 | Terminated |
| 12 Aug 2016 | PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040. Radiological image processing system (Computed Radiography). | Device | Class II | 1 | Terminated |
| 26 Jul 2016 | IntelliVue Patient Monitor Product Usage: The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological… | Device | Class II | 1 | Terminated |
| 19 Jul 2016 | MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038. | Device | Class II | 3 | Terminated |
| 7 Jul 2016 | Allura Xper with release R8.2: Allura Xper FD10, 722026; Allura Xper FD10/10, 722027; Allura Xper FD20, 722028; Allura Xper FD20/10 biplane, 722029; Allura Xper FD10 OR Table, 722033; Allura Xper FD10/10 OR Table, 722034; Allura Xper FD20 OR Table, 722035; Allure Xper FD20/20 , 722038; Allura Xper FD20/20 biplane OR… | Device | Class II | 2 | Terminated |
| 14 Apr 2016 | HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or… | Device | Class II | 1 | Terminated |
| 15 Mar 2016 | Philips Healthcare System X-ray Tomography Computed : | Device | Class II | 2 | Terminated |
| 10 Feb 2016 | evaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim A disposable heel warmer for use when circulation needs to be stimulated in the infant heel in order for blood sampling to occur | Device | Class II | 2 | Terminated |
| 4 Jan 2016 | Philips IntelliVue Measurement Module X1 Model: M3001A | Device | Class II | 2 | Terminated |
| 25 Nov 2015 | Philips Healthcare IntelliVue Info Center iX, A.0 866023 | Device | Class II | 3 | Terminated |
| 20 Nov 2015 | Cardinal Health Tiny Toes; 11470-010T Infant heel warmer | Device | Class II | 1 | Terminated |
| 3 Nov 2015 | Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications. | Device | Class II | 2 | Terminated |
| 3 Nov 2015 | Allura Xper FD10, FD10 C, and FD10 F; Model Numbers: 722026 722010 722003 722002 722001 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP). | Device | Class II | 29 | Terminated |
| 14 Oct 2015 | Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. For use for the termination of ventricular tachycardia and ventricular fibrillation. | Device | Class II | 1 | Terminated |
| 1 Oct 2015 | Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and… | Device | Class II | 1 | Terminated |
| 17 Sep 2015 | Philips DuraDiagnost stationary X-ray system | Device | Class II | 1 | Terminated |
| 22 Jul 2015 | Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diagnosis. | Device | Class II | 1 | Terminated |
| 6 Jul 2015 | SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system | Device | Class II | 1 | Terminated |
| 6 Jul 2015 | Actuator for angiographic x-ray monitor ceiling suspension system. Actuator short Assy: THC8AWDS-121 and Actuator long Assy: THC8AWDS-122 used with the following products: 722001 Allura Xper FD 10 C; 722003 Allura Xper FD10; 722005 Allura Xper FD10/10; 722006 Allura Xper FD20; 722008 Allura Xper FD20 Biplane; 722010… | Device | Class II | 1 | Terminated |
| 17 Jun 2015 | Invivo Expression MRI Patient Monitoring System. | Device | Class II | 1 | Terminated |
| 5 Jun 2015 | Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation. When operating as a semi-automatic… | Device | Class II | 1 | Terminated |
| 14 Apr 2015 | Philips Healthcare Brilliance 64 Computed Tomography X-ray system | Device | Class II | 4 | Terminated |
| 23 Mar 2015 | Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 Product Usage: The DigitalDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctors or technicians. | Device | Class II | 1 | Terminated |
| 19 Nov 2014 | ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for Synchronized cardioversion and Transcutaneous pacing. M1783A/M5526A 12-pin Sync cables, used with HeartStart MRx and HeartStart XL and HeartStart XL+ | Device | Class II | 1 | Terminated |
| 31 Jul 2014 | Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001, 459800220161, 459800232931, 459800235871, 459800338451. UPDATED: Pinnacle3 Software Version 8.0h, 8.0k, 8.0m, 8.0n. | Device | Class II | 1 | Terminated |
| 17 Dec 2010 | M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 865009, 865011, 865012, 865091, 865092, 865093, 865094, 865095, 865096, 865098, 865099, 865102, 865104, 865105, 865125, 865127. The intended use of the Information Center Software is to display physiologic waves, parameters and… | Device | Class II | 1 | Terminated |