Philips Medical Systems North America, Inc.
Philips Medical Systems North America, Inc. holds FDA 510(k) medical device clearances, first cleared 1989, most recent 2010, with 5 FDA device recalls on record.
Top product codes for Philips Medical Systems North America, Inc.
FDA recalls by Philips Medical Systems North America, Inc.
- Z-1263-2014 — Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206 EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of Doppler velocity results values are used to assist in diagnosing the existence, location and severity of cardiac or vasculare stenosis.
- Z-1264-2014 — Philips Model EPIQ 7 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206 EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of Doppler velocity results values are used to assist in diagnosing the existence, location and severity of cardiac or vasculare stenosis.
- Z-1225-2014 — Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389. The HeartStart FR3 is a battery powered automated external defibrillator (AED) designed for use by responders who have been trained in Basic Life Support (BLS), Advanced Life Support (ALS), or another physician-authorized emergency medical response program. The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardia (VTs). Both models are used with disposable defibrillator pads applied to potential victims of SCA with the following symptoms: -Unresponsiveness -Absence of normal breathing If in doubt, apply the pads. The HeartStart FR3 is intended for adults and children over 55 pounds (25 kg) or 8 years old. Both models 861388 and 861389 are also intended for children under 55 pounds (25 kg) or 8 years old when used with the optional Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child's age or weight, do not delay treatment.
- Z-1232-2014 — Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when shaken -Not breathing normally If in doubt, apply the pads. A training class in CPR/AED use is recommended for anyone who may use the HS1. If the person is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), use the special infant/child pads. If the child appears older/larger, use the adult pads. Do not delay treatment to determine the child s exact age or weight. If in doubt, use the adult pads. Models M5066A (for HS1 Onsite), M5067A (OnSite) , and M5068A (for HS1 Home).
- Z-0368-2014 — EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis.
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 North America, Inc.
- K102005 — ALLURA XPER OR TABLE SERIES
- K062233 — HEARTSTART MRX MONITOR/DEFIBRILLATOR
- K062283 — THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORS
- K061052 — THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90
- K050151 — MULTIDIAGNOST ELEVA
- K042867 — PHILIPS ORTHOPAEDIC APPLICATIONS
- K041602 — PANORAMA 1.0T
- K033737 — ALLURA XPER FD20
- K031333 — PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2
- K013894 — TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T
- K003459 — PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FLOW
- K003516 — GYROSCAN INTERA 3.0T
- K002942 — PHILIPS EASY VISION FAMILY WORKSTATION OPTION CARDIRAC SCORING
- K001796 — GYROSCAN INTERA (R7.5)
- K001987 — EXPLORER GRADIENT
- K002016 — PHILIPS INTEGRIS ALLURA
- K001331 — SYNERGY HEAD/NECK COIL
- K000819 — PHILIPS CT SECURA MV
- K000832 — STEROTACTIC LOCALIZATION DEVICE (SLD)
- K993227 — PHILIPS INTURIS DICOM RECORDER
- K990329 — PHILIPS EASYVISION WORKSTATION
- K992533 — PHILIPS GYROSCAN INTERA (*)
- K990335 — PHILIPS EASYVISION WORKSTATION:
- K991765 — SYNERGY SHOULDER COIL
- K991278 — PHILIPS TOMOSCAN AV-NT
- K984545 — RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS
- K983877 — PHILIPS INTEGRIS 3D RA OPTION
- K983821 — PHILIPS INTURIS CARDIO IMAGE VIEWING PACKAGE
- K983140 — CT BIOPSYVIEW
- K983069 — PHILIPS DUO DIAGNOST
- K982834 — RESTGRID PACKAGE/GYROSCAN NT
- K981657 — PHILIPS THORAVISION
- K980645 — PHILIPS GYROSCAN NT RELEASE 6 SERIES
- K973658 — DIFFUSION PACKAGE / GYROSCAN NT
- K974207 — PHILIPS EASYVISION WORKSTATION
- K973482 — PHILIPS INTEGRIS V5000 AND BV5000
- K972103 — PHILIPS EASYVISION
- K971489 — RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4
- K971365 — PHILIPS INTEGRIS H5000
- K970640 — PHILIPS EASY DIAGNOST
- K964318 — PHILIPS TOMOSCAN AV EXPANDER UPGRADE
- K963980 — PHILIPS EASYVISION
- K960809 — PHILIPS SITE VIEW WORKSTATION
- K945945 — GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NT
- K953910 — PHILIPS BV 300 SERIES
- K954255 — PHILIPS TOMOSCAN SR 8000
- K945460 — PHILIPS CD MEDICAL RECORDER, VIEW STATION, DUP[[LICATION STATION
- K943464 — PHILIPS IMPROVED CHECK RADIOGRAPH OPTION
- K945278 — PHILIPS BUCKY DIAGNOST FAMILY
- K944326 — PHILIPS TOMOSCAN SR5000
- K936272 — PHILIPS TOMOSCAN SR 4000
- K943381 — LASER ALIGNMENT TOOL
- K940696 — SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5
- K933791 — PHILIPS ANGIOPRO RELEASE 2.1
- K933650 — PHILIPS XRG 90 X-RAY GENERATOR SYSTEM
- K923944 — PHILIPS GYROVIEW HR - RELEASE 2
- K920578 — PHILIPS GYROSCAN T5 SERIES II
- K911888 — PHILIPS ANGIOPRO
- K912752 — PHILIPS TOMOSCAN SR
- K902926 — COLOR VELOCITY IMAGING (CVI) OPTION FOR PLATINUM
- K902542 — PHILIPS INTEGRIS C2000 SYSTEM
- K900002 — DOPPLER OPTION FOR PLATINUM
- K900660 — TOMOSCAN STEREOTAXIS SIMULATION SOFTWARE
- K896609 — CYTOGUIDE FOR USE W/THE PHILMEDISYST MAMMODIAG UC
- K896647 — GYROVIEW HR HIGH RESOLUTION WORKSTATION
- K891292 — SRS-200 RADIOSURGERY SYSTEM
- K890351 — ORTHORALIX SD/ORTHORALIX SD CEPH
- K885327 — PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM
- K890789 — GYROSCAN T5 MAGNETIC RESONANCE DIAGNOSTIC DEVICE
- K885020 — CYTOGUIDE
- K891293 — SLS SIMULATOR (MODELS SLS-9 AND SLS-14)
Data sourced from openFDA. This site is unofficial and independent of the FDA.