Philips North America
FDA Regulatory Profile
Philips North America appears in FDA public data with 538 recalls — including 9 Class I (most serious) —, 1 510(k) clearance, 20 FDA inspections, and 4 compliance actions on record. Its most recent recall (Z-3040-2026, Class II) was initiated on Aug 7, 2026. Its most recent 510(k) clearance was granted on Jan 11, 2021.
Summary
- Total Recalls
- 538 (9 Class I)
- 510(k) Clearances
- 1
- Inspections
- 20
- Compliance Actions
- 4
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-3040-2026 | Class II | Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1 | Aug 7, 2026 |
| Z-3042-2026 | Class II | Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ing | Aug 7, 2026 |
| Z-3041-2026 | Class II | Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Softwa | Aug 7, 2026 |
| Z-3043-2026 | Class II | Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades P | Aug 7, 2026 |
| Z-3141-2026 | Class II | Philips Patient Information Center iX REF:866389 | Jul 31, 2026 |
| Z-3142-2026 | Class II | Philips PIC iX Essentials REF:867093 | Jul 31, 2026 |
| Z-2955-2026 | Class II | Cardiac Workstation 5000. Product Number: 860439. | Jul 1, 2026 |
| Z-2956-2026 | Class II | Cardiac Workstation 7000. Product Number: 860441. | Jul 1, 2026 |
| Z-2579-2026 | Class II | Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descript | Jun 5, 2026 |
| Z-2523-2026 | Class II | Philips Avalon Fetal Monitor, FM 30 Part numberM2703A | May 26, 2026 |
| Z-2522-2026 | Class II | Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A | May 26, 2026 |
| Z-2354-2026 | Class II | DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035. | May 1, 2026 |
| Z-1965-2026 | Class II | Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. | Apr 14, 2026 |
| Z-1966-2026 | Class II | Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145. | Apr 14, 2026 |
| Z-1962-2026 | Class II | Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Mode | Apr 14, 2026 |
| Z-1959-2026 | Class II | Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model | Apr 14, 2026 |
| Z-1964-2026 | Class II | Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number ( | Apr 14, 2026 |
| Z-1961-2026 | Class II | Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Mod | Apr 14, 2026 |
| Z-1957-2026 | Class II | Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262. | Apr 14, 2026 |
| Z-1956-2026 | Class II | Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Num | Apr 14, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K203231 | Switched Internal Paddles | Jan 11, 2021 |