Philips Medical Systems Technologies Ltd.

FDA Regulatory Profile

Philips Medical Systems Technologies Ltd. appears in FDA public data with 1 recall, 5 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0497-2025, Class II) was initiated on October 10, 2024. Its most recent 510(k) clearance was granted on March 27, 2026.

Summary

Total Recalls
1
510(k) Clearances
5
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0497-2025Class IIVue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 114941October 10, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K253649Spectral CT Verida FamilyMarch 27, 2026
K244008Spectral CTMay 16, 2025
K240844Spectral CT 7500 RTOctober 18, 2024
K240822Image Management V15April 24, 2024
K173588Illumeo SystemJanuary 12, 2018