Philips Medical Systems Nederlands

FDA Regulatory Profile

Summary

Total Recalls
79
510(k) Clearances
8
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1240-2019Class IIIngenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), March 25, 2019
Z-1141-2019Class IIFoot Switches used with the following systems: 722001 Allura Xper FD 10 C 722002 Allura Xper FD1February 19, 2019
Z-1140-2019Class IIFoot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 70803February 19, 2019
Z-0915-2019Class IIAchieva 1.5T Conversion, Model Number 781346. Nuclear Magnetic Resonance Imaging SystemDecember 21, 2018
Z-0924-2019Class IIMR-OR 1.5T, Model Number 781437. Nuclear Magnetic Resonance Imaging SystemDecember 21, 2018
Z-0901-2019Class IIIngenia 1.5T CX, Model Number 781261. Nuclear Magnetic Resonance Imaging SystemDecember 21, 2018
Z-0880-2019Class IIIntera 1.5T CV, Model Number 781107. Nuclear Magnetic Resonance Imaging SystemDecember 21, 2018
Z-0919-2019Class IIIngenia 1.5T, Model Number 781396. Nuclear Magnetic Resonance Imaging SystemDecember 21, 2018
Z-0902-2019Class IIIngenia 1.5T CX (ZBO), Model Number 781262. Nuclear Magnetic Resonance Imaging SystemDecember 21, 2018
Z-0890-2019Class IIIntera 1.5T Achieva CV Nova, Model Number 781174. Nuclear Magnetic Resonance Imaging SystemDecember 21, 2018
Z-0869-2019Class IIProdiva CS, Model Number 781069. Nuclear Magnetic Resonance Imaging SystemDecember 21, 2018
Z-0932-2019Class IIMultiva 1.5T, Model Number 781076. Nuclear Magnetic Resonance Imaging SystemDecember 21, 2018
Z-0918-2019Class IIIngenia 3.0T, Model Number 781377. Nuclear Magnetic Resonance Imaging SystemDecember 21, 2018
Z-0920-2019Class IIIngenia Ambition S, Model Number 781359. Nuclear Magnetic Resonance Imaging SystemDecember 21, 2018
Z-0927-2019Class IIAchieva 3.0T for PET, Model Number 781477. Nuclear Magnetic Resonance Imaging SystemDecember 21, 2018
Z-0887-2019Class IIIntera Achieva 1.5T Pulsar, Model Number 781171. Nuclear Magnetic Resonance Imaging SystemDecember 21, 2018
Z-0893-2019Class IIAchieva 3.0T, Model Number 781177. Nuclear Magnetic Resonance Imaging SystemDecember 21, 2018
Z-0914-2019Class IIAchieva 3.0T TX, Model Number 781345. Nuclear Magnetic Resonance Imaging SystemDecember 21, 2018
Z-0870-2019Class IIProdiva CX, Model Number 781070. Nuclear Magnetic Resonance Imaging SystemDecember 21, 2018
Z-0883-2019Class IIIntera 3.0T Master/Quasar Dual, Model Number 781150. Nuclear Magnetic Resonance Imaging SystemDecember 21, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K240224Zenition 90May 22, 2024
K223442MR 5300 and MR 7700 R11 MR SystemsDecember 23, 2022
K201743ClarifEye R1.0, ClarifEye NeedleFebruary 23, 2021
K181311Philips Hemodynamic Application R1.0September 7, 2018
K181966SmartPerfusionAugust 17, 2018
K162025IntelliSpace Portal PlatformOctober 18, 2016
K153324Ingenia 1.5T and Ingenia 1.5T S R5.2March 22, 2016
K143128mDIXON XDMarch 20, 2015