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-1140-2019Class IIFoot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 70803February 19, 2019
Z-1141-2019Class IIFoot Switches used with the following systems: 722001 Allura Xper FD 10 C 722002 Allura Xper FD1February 19, 2019
Z-0925-2019Class IIMR-OR 3.0T, Model Number 781438. Nuclear Magnetic Resonance Imaging SystemDecember 21, 2018
Z-0908-2019Class IIIntera 1.5T High Performance, Model Number 781295. Nuclear Magnetic Resonance Imaging SystemDecember 21, 2018
Z-0904-2019Class IIIngenia 3.0T CX, Model Number 781271. Nuclear Magnetic Resonance Imaging SystemDecember 21, 2018
Z-0929-2019Class IINZM101 Ingenia 1.5T Linac, Model Number 781483. Nuclear Magnetic Resonance Imaging SystemDecember 21, 2018
Z-0886-2019Class IIIntera 1.5T R11, Model Number 781170. Nuclear Magnetic Resonance Imaging SystemDecember 21, 2018
Z-0897-2019Class IIAchieva 7.0T, Model Number 781240. Nuclear Magnetic Resonance Imaging SystemDecember 21, 2018
Z-0910-2019Class IIIngenia 1.5T, Model Number 781341. Nuclear Magnetic Resonance Imaging SystemDecember 21, 2018
Z-0878-2019Class IIIntera 1.5T Power/Pulsar, Model Number 781105. Nuclear Magnetic Resonance Imaging SystemDecember 21, 2018
Z-0921-2019Class IIIngenia Ambition X, Model Number 781356. Nuclear Magnetic Resonance Imaging SystemDecember 21, 2018
Z-0919-2019Class IIIngenia 1.5T, Model Number 781396. Nuclear Magnetic Resonance Imaging SystemDecember 21, 2018
Z-0912-2019Class IIAchieva 1.5T, Model Number 781343. Nuclear Magnetic Resonance Imaging SystemDecember 21, 2018
Z-0903-2019Class IISmartPath to dStream for XR and 3.0T, Model Number 781270. Nuclear Magnetic Resonance Imaging SystDecember 21, 2018
Z-0885-2019Class IIIntera IT, Model Number 781160. Nuclear Magnetic Resonance Imaging SystemDecember 21, 2018
Z-0884-2019Class IIAchieva XR 1.5T/3.0T, Model Number 781153. Nuclear Magnetic Resonance Imaging SystemDecember 21, 2018
Z-0893-2019Class IIAchieva 3.0T, Model Number 781177. Nuclear Magnetic Resonance Imaging SystemDecember 21, 2018
Z-0913-2019Class IIAchieva 3.0T X, Model Number 781344. Nuclear Magnetic Resonance Imaging SystemDecember 21, 2018
Z-0914-2019Class IIAchieva 3.0T TX, Model Number 781345. 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