Philips Medical Systems, Inc.
Philips Medical Systems, Inc. holds FDA 510(k) medical device clearances, first cleared 1983, most recent 2010, with 65 FDA device recalls on record.
Top product codes for Philips Medical Systems, Inc.
FDA recalls by Philips Medical Systems, Inc.
10 most recent of 65- Z-1643-2015 — Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle 3 RTP software allows qualified medical professionals to enter patient data into the system, use that data to construct a plan for radiation therapy and evaluate the plan. Optionally, the qualified medical personnel may output the plan in an electronic or printed form for use by other systems in the delivery of treatment to a patient.
- Z-1555-2015 — Philips Healthcare DuraDiagnost X- Ray
- Z-1554-2015 — Philips Healthcare DigitalDiagnost System X-Ray
- Z-0351-2016 — Philips Healthcare Xper cardio systems Model : 722123 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and thrombolysis and atherectomics), pacemaker Implantations and electrophysiology (EP). Use of the Allura Xper series system in the OR environment is restricted; the system should only be used for endo-vascular procedures. The Philips Integris Allura 9F is intended for diagnostic cardiovascular, vascular and interventional procedures
- Z-0347-2016 — Philips Healthcare Allure BiPlane Series: Model 722013 Allura Xper FD20 BIPLANE R7.6 722013 Allura Xper FD20 BIPLANE R7.7 722013 Allura Xper FD20 BIPLANE R7.8 722013 Allura Xper FD20 BIPLANE R7.9 722013 Allura Xper FD20 BIPLANE R7.10 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and thrombolysis and atherectomics), pacemaker Implantations and electrophysiology (EP). Use of the Allura Xper series system in the OR environment is restricted; the system should only be used for endo-vascular procedures. The Philips Integris Allura 9F is intended for diagnostic cardiovascular, vascular and interventional procedures
- Z-0348-2016 — Philips Healthcare INTEGRIS cardio system Model : 722121 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and thrombolysis and atherectomics), pacemaker Implantations and electrophysiology (EP). Use of the Allura Xper series system in the OR environment is restricted; the system should only be used for endo-vascular procedures. The Philips Integris Allura 9F is intended for diagnostic cardiovascular, vascular and interventional procedures
- Z-0350-2016 — Philips Healthcare INTEGRIS H5000F/Allura 9F Model : 722017 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and thrombolysis and atherectomics), pacemaker Implantations and electrophysiology (EP). Use of the Allura Xper series system in the OR environment is restricted; the system should only be used for endo-vascular procedures. The Philips Integris Allura 9F is intended for diagnostic cardiovascular, vascular and interventional procedures
- Z-0349-2016 — Philips Healthcare INTEGRIS vascular System Model : 722122 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and thrombolysis and atherectomics), pacemaker Implantations and electrophysiology (EP). Use of the Allura Xper series system in the OR environment is restricted; the system should only be used for endo-vascular procedures. The Philips Integris Allura 9F is intended for diagnostic cardiovascular, vascular and interventional procedures
- Z-0352-2016 — Philips Healthcare Xper vascular system Model : 722124 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and thrombolysis and atherectomics), pacemaker Implantations and electrophysiology (EP). Use of the Allura Xper series system in the OR environment is restricted; the system should only be used for endo-vascular procedures. The Philips Integris Allura 9F is intended for diagnostic cardiovascular, vascular and interventional procedures
- Z-0346-2016 — Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10 Allura Xper FD20 Allura Xper FD21 Allura Xper FD22 Allura Xper FD23 Allura Xper FD24 Allura Xper FD25 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and thrombolysis and atherectomics), pacemaker Implantations and electrophysiology (EP). Use of the Allura Xper series system in the OR environment is restricted; the system should only be used for endo-vascular procedures. The Philips Integris Allura 9F is intended for diagnostic cardiovascular, vascular and interventional procedures
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Philips Medical Systems, Inc.
1–100 of 111- K093355 — PCR ELEVA 1.2
- K090808 — PINNACLE3 SMARTARC
- K071391 — PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521
- K063783 — PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A
- K041741 — M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN
- K040955 — M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN
- K040404 — HEARTSTART MRX, MODEL M3535A
- K040357 — M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A TELEMETRY MONITORING SYSTEM II
- K032979 — PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T
- K033715 — PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER
- K033662 — SYNERGY SPINE ARRAY COIL
- K033326 — PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM
- K032046 — PHILLIPS OMNIDIAGNOST ELEVA
- K031403 — M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.1
- K030731 — M2376A DEVICELINK SYSTEM
- K030038 — PHILIPS MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS WITH PORTAL TECHNOLOGY AND M3185 OPT C41 WIRELESS BEDSIDE ADAPTR
- K023931 — PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A
- K024042 — PANORAMA ENHANCEMENTS
- K013644 — ACQPLAN 5.0
- K021912 — M2376 DEVICELINK SYSTEM
- K020708 — PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES
- K020494 — MODIFICATION TO M2376A DEVICELINK SYSTEM
- K014261 — ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE E.0
- K014159 — PHILLIPS M1175A/76A/77A COMPONENT MONITORING SYSTEM; PHILLIPS V24/V26 PATIENT MONITOR
- K014181 — M2376A DEVICELINK SYSTEM, MODEL M2376A
- K013427 — MODIFICATION TO:PHILIPS M3000A/M3046A COMPACT PORTABLE PATIENT MONITOR, MODELS PHILIPS M3000A/M3046A
- K013199 — PHILIPS COMPONENT COMPACT MONITOR,MODEL M1275B, PHILIPS COMPENENT RACK, MODEL M1276B
- K013470 — MODIFICATION TO M2376A DEVICELINK SYSTEM
- K010762 — PHILIPS BV LIBRA
- K010435 — PHILIPS BV PULSERA/ENDURA
- K994210 — INTURIS SUITE
- K990455 — PHILIPS EASY VISION FAMILY WORKSTATION LEGS OPTION
- K990423 — PHILIPS NICOL COLLIMATOR FAMILY
- K981480 — PHILIPS EASYGUIDE
- K982795 — PHILIPS BUCKY VISION
- K980820 — PHILIPS EASYGUIDE
- K982631 — PHILIPS TOMOSCAN CS
- K982993 — PHILIPS OMNIDIAGNOST
- K982706 — PHILIPS BV300 SERIES RELEASE 2.1
- K971965 — PHILIPS EASYVISION
- K973983 — PHILLIPS EASY VISION FAMILY WORKSTATION OPTION ENDO 3D
- K973835 — PHILIPS EASYVISION WORKSTATION
- K963990 — GYROSCAN T5-NT, GYROSCAN T10-NT AND GYROSCAN ACS-NT RELEASE 5 SERIES
- K964124 — PHILIPS COMPUTED RADIOGRAPHY
- K963624 — PHILIPS SLI SERIES LINEAR ACCELERATOR
- K961834 — PHILIPS EASYGUIDE NEURO
- K961374 — PHILIPS MULTIDIAGNOST 4
- K953911 — PHILIPS EASYVISION
- K953095 — PHILIPS EASYVISION
- K953570 — PHILIPS MULTI LEAF PRESCRIPTION ENTRY SYSTEM (MLP)
- K952704 — PHILIPS EASYVISION
- K951372 — PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE)
- K940534 — GYROSCAN T10-NT (RELEASE 4 SERIES SOFTWARE)
- K931071 — PHILIPS THORAVISION
- K930193 — PHILIPS ENDO-CAVITARY MRI COIL
- K921219 — PHILIPS DCI-SX
- K930708 — PHILIPS GYROSCAN T5 II RELEASE 3
- K932644 — PHILIPS GYROSCAN TN5 & TN5 LITE
- K932645 — PHILIPS GYROSCAN TN 15
- K924184 — CVI-Q(TM) OPTION FOR P700
- K930709 — PHILIPS GYROSCAN ACS-II RELEASE 3
- K926275 — PHILIPS MRI BREAST COIL
- K924495 — PHILIPS RTNET RADIOTHERAPY NETWORKING SYSTEM
- K923481 — PHILIPS LASER DISK ARCHIVE
- K924082 — PHILIPS TOMOSCAN SR7000 CT SYSTEMS
- K923141 — PHILIPS PRE-FILTER OPTION
- K925105 — PHILIPS MEDIO CP FAMILY
- K925844 — PHILIPS SUPER CP FAMILY
- K925302 — PHILIPS INTEGRIS H/HM SYSTEM
- K924593 — DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4
- K920791 — GYROSCAN S15/ACS-II
- K923813 — PHILIPS INTEGRIS V3000 ROTATIONAL ANGIO FUNCTION
- K922622 — PHILIPS CARDIAC WORKSTATION
- K920793 — PHILIPS DSI SYSTEM RELEASE 3.2
- K921255 — PHILIPS BV26 MOBILE C-ARM STAND
- K921101 — PHILIPS INTEGRIS V3000 FILM
- K920950 — PHILIPS EASYVISION
- K915237 — PHILIPS PCR-ACE SYSTEM
- K913845 — PHILIPS MAMMODIAGNOST BC
- K911872 — PHILIPS RIGID VOLUME COILS
- K913029 — GYROVIEW-HR
- K912470 — PHILIPS DIAGNOST 96
- K911098 — PHILIPS URO DIAGNOST MRF
- K911773 — PHILIPS TELESCAN
- K910370 — PHILIPS INTEGRIS V3000 AND V4000
- K905603 — PHILIPS GYROVIEW-HR IMAGING WORKSTATION
- K910115 — PHILIPS BV-29 IMAGING SYSTEM
- K904124 — PHILIPS MULTILEAF COLLIMATOR (MLC)
- K902691 — DOPPLER OPTION FOR PLATINUM
- K904012 — PHILIPS INTEGRIS I 2000 SYSTEM
- K902799 — GYROSCAN S15/ACS
- K902849 — PHILIPS VERIFLEX
- K895869 — GYROSCAN T5 MOBILE
- K894912 — SRI 100 RADIOTHERAPY IMAGING SYSTEM
- K894123 — VERICORD S3
- K892845 — SOFTWARE RELEASE 1.3 FOR THE SL SERIES LINEAR ACCE
- K893131 — DIGITAL SPOT IMAGING (DSI)
- K883264 — SL SERIES ACCELERATORS SL15, SL18, SL20 & SL25
- K883067 — MODIFIED SL-SERIES LINEAR ACCELERATORS
- K882231 — SL SERIES, SL 15, 18, 20 & 25 (MODIFICATION)
Data sourced from openFDA. This site is unofficial and independent of the FDA.