Philips Electronics North America Corporation

FDA Regulatory Profile

Summary

Total Recalls
160
510(k) Clearances
0
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0614-2019Class IIXper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model NumberNovember 15, 2018
Z-0592-2019Class IIIntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: IndicateOctober 10, 2018
Z-3223-2018Class IIAllura Xper FD2O Biplane, System Code 722013 Vascular, cardiovascular and neurovascular imaging July 16, 2018
Z-3233-2018Class IIAllura Xper F010 DR Table, System Code 722014 Vascular, cardiovascular and neurovascular imagingJuly 16, 2018
Z-3215-2018Class IIINTEGRIS CV, System Code 722030 Vascular, cardiovascular and neurovascular imaging applications,July 16, 2018
Z-3220-2018Class IINTEGRIS Allura 9 0 FDXD, System Code 722498 Vascular, cardiovascular and neurovascular imaging July 16, 2018
Z-3224-2018Class IIAllura Xper FD2O Biplane, System Code 722008 Vascular, cardiovascular and neurovascular imaging July 16, 2018
Z-3239-2018Class IICesar Powerpack-Visub(V3000), System Code 72243 Vascular, cardiovascular and neurovascular imagiJuly 16, 2018
Z-3235-2018Class IIAllura Xper F010/10 DRTable, System Code 722019 Vascular, cardiovascular and neurovascular imagiJuly 16, 2018
Z-3234-2018Class IIAllura Xper F020 DR Table, System Code 722015 Vascular, cardiovascular and neurovascular imagingJuly 16, 2018
Z-3232-2018Class IIAllura Xper F020 DR Table, System Code 722023 Vascular, cardiovascular and neurovascular imagingJuly 16, 2018
Z-3236-2018Class IIAllura Xper F020 Biplane DR Table, System Code 722020 Vascular, cardiovascular and neurovascularJuly 16, 2018
Z-3225-2018Class IIAllura Xper FD1O C, System Code 722001 Vascular, cardiovascular and neurovascular imaging applicJuly 16, 2018
Z-3214-2018Class IIINTEGRIS Allura 9 (biplane), System Code 722021 Vascular, cardiovascular and neurovascular imagiJuly 16, 2018
Z-3238-2018Class IICesar-DMCP-Visub(HM2000/3000), System Code 72239 Vascular, cardiovascular and neurovascular imaJuly 16, 2018
Z-3219-2018Class IIINTEGRIS Allura 9 F FDXD, System Code 722497 Vascular, cardiovascular and neurovascular imaging July 16, 2018
Z-3237-2018Class IIPoly C- DMCP-Visub(H3000), System Code 72238 Vascular, cardiovascular and neurovascular imaging July 16, 2018
Z-3228-2018Class IIAlluraXperFOlO/lO, System Code 722005 Vascular, cardiovascular and neurovascular imaging applicaJuly 16, 2018
Z-3213-2018Class IIINTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovascular imaging applicaJuly 16, 2018
Z-3218-2018Class IIINTEGRIS SUITE, System Code 722199 Vascular, cardiovascular and neurovascular imaging applicatioJuly 16, 2018