Philips Medical Systems Gmbh, DMC

FDA Regulatory Profile

Summary

Total Recalls
33
510(k) Clearances
1
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2357-2021Class IICombiDiagnost R90 Software Version R1.0 and R1.1July 22, 2020
Z-1328-2020Class IICombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, December 19, 2019
Z-1329-2020Class IICombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, December 19, 2019
Z-0612-2019Class IIStationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-raNovember 7, 2018
Z-0239-2019Class IIPhilips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models: 712027, 712028,September 19, 2018
Z-2849-2018Class IIDigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029June 27, 2018
Z-2850-2018Class IIDigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028June 27, 2018
Z-2867-2018Class IIEasyDiagnost Eleva DRF (Stitching Patient Support) 706032June 27, 2018
Z-2863-2018Class IIDigitalDiagnost Single Detector (Stitching Patient Support) 712020June 27, 2018
Z-2847-2018Class IICombiDiagnost R90 (Stitching Patient Support) 709030June 27, 2018
Z-2856-2018Class IIDigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081June 27, 2018
Z-2855-2018Class IIDigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031June 27, 2018
Z-2858-2018Class IIDigitalDiagnost Dual Detector (Stitching Patient Support) 712022June 27, 2018
Z-2861-2018Class IIDigitalDiagnost Release 3 (Stitching Patient Support) 712025June 27, 2018
Z-2848-2018Class IIDigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712081June 27, 2018
Z-2865-2018Class IIDigitalDiagnost, Dual-Detector (Stitching Patient Support) 712052June 27, 2018
Z-2866-2018Class IIDigitalDiagnost, Single-Detect (Stitching Patient Support) 712062June 27, 2018
Z-2842-2018Class IIDigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028June 27, 2018
Z-2845-2018Class IIDigitalDiagnost Release 3.1 (Stitching Patient Support) 712026June 27, 2018
Z-2868-2018Class IIEasyDiagnost Eleva DRF, Release 5 (Stitching Patient Support) 706050June 27, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K070528PHILIPS ESSENTA DRMarch 9, 2007