Philips North America Llc
FDA Regulatory Profile
Philips North America Llc appears in FDA public data with 530 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-2579-2026, Class II) was initiated on June 5, 2026. Its most recent 510(k) clearance was granted on January 11, 2021.
Summary
- Total Recalls
- 530 (9 Class I)
- 510(k) Clearances
- 1
- Inspections
- 20
- Compliance Actions
- 4
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2579-2026 | Class II | Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descript | June 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-1951-2026 | Class II | Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Numb | April 14, 2026 |
| Z-1969-2026 | Class II | Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130. | April 14, 2026 |
| Z-1959-2026 | Class II | Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model | April 14, 2026 |
| Z-1965-2026 | Class II | Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. | April 14, 2026 |
| Z-1957-2026 | Class II | Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262. | April 14, 2026 |
| Z-1960-2026 | Class II | Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Mod | April 14, 2026 |
| Z-1953-2026 | Class II | Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278. | April 14, 2026 |
| Z-1967-2026 | Class II | Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): | April 14, 2026 |
| Z-1963-2026 | Class II | Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Mode | April 14, 2026 |
| Z-1958-2026 | Class II | Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Num | April 14, 2026 |
| Z-1966-2026 | Class II | Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145. | April 14, 2026 |
| Z-1955-2026 | Class II | Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. | April 14, 2026 |
| Z-1952-2026 | Class II | Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178. | April 14, 2026 |
| Z-1956-2026 | Class II | Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Num | April 14, 2026 |
| Z-1961-2026 | Class II | Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Mod | April 14, 2026 |
| Z-1964-2026 | Class II | Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number ( | April 14, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K203231 | Switched Internal Paddles | January 11, 2021 |