Philips Ultrasound, Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 134
- 510(k) Clearances
- 71
- Inspections
- 6
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0883-2026 | Class II | Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841, | October 31, 2025 |
| Z-1624-2026 | Class III | Philips OMNI III TEE Ultrasound Transducer | September 5, 2025 |
| Z-1626-2026 | Class III | Philips S5-2 Ultrasound Transducer | September 5, 2025 |
| Z-1621-2026 | Class III | Philips L17-5 Ultrasound Transducer | September 5, 2025 |
| Z-1618-2026 | Class III | Philips 3D6-2 Ultrasound Transducer | September 5, 2025 |
| Z-1620-2026 | Class III | Philips L12-5 Ultrasound Transducer | September 5, 2025 |
| Z-1623-2026 | Class III | Philips OMNI II TEE Ultrasound Transducer | September 5, 2025 |
| Z-1622-2026 | Class III | Philips Mini Multi TEE Ultrasound Transducer | September 5, 2025 |
| Z-1619-2026 | Class III | Philips C9-4 Ultrasound Transducer | September 5, 2025 |
| Z-1627-2026 | Class III | Philips X3-1 Ultrasound Transducer | September 5, 2025 |
| Z-1625-2026 | Class III | Philips S4-1 Ultrasound Transducer | September 5, 2025 |
| Z-1628-2026 | Class III | Philips X7-2 Ultrasound Transducer | September 5, 2025 |
| Z-2386-2025 | Class III | mL26-8 Transducer Probe | July 3, 2025 |
| Z-2411-2025 | Class III | X7-2 Transducer Probe | July 3, 2025 |
| Z-2346-2025 | Class III | 3D6-2 Transducer Probe | July 3, 2025 |
| Z-2392-2025 | Class III | S4-1 Lumify Transducer Probe | July 3, 2025 |
| Z-2379-2025 | Class III | L17-5 Transducer Probe | July 3, 2025 |
| Z-2394-2025 | Class III | S5-2 Transducer Probe | July 3, 2025 |
| Z-2373-2025 | Class III | L12-4 Transducer Probe | July 3, 2025 |
| Z-2408-2025 | Class III | X5-1 Transducer Probe | July 3, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253595 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | March 27, 2026 |
| K252557 | Lumify Diagnostic Ultrasound System | December 22, 2025 |
| K251651 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | October 9, 2025 |
| K251455 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | July 24, 2025 |
| K250886 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | June 18, 2025 |
| K243793 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | May 21, 2025 |
| K242519 | Lumify Diagnostic Ultrasound System | May 15, 2025 |
| K251110 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | May 9, 2025 |
| K242670 | Lumify Diagnostic Ultrasound System | May 8, 2025 |
| K250030 | Flash Ultrasound System 5100 Point of Care | April 28, 2025 |
| K250177 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | April 10, 2025 |
| K241659 | Ultrasound Workspace (UWS 6.0) | February 10, 2025 |
| K243794 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | February 6, 2025 |
| K242020 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | December 12, 2024 |
| K242800 | The 5000 Compact Series Ultrasound Systems | November 15, 2024 |
| K240980 | EPIQ Series Diagnostic Ultrasound System | October 7, 2024 |
| K240850 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | April 24, 2024 |
| K233788 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | February 13, 2024 |
| K233545 | EPIQ Series Diagnostic Ultrasound System | November 30, 2023 |
| K232500 | Lumify Diagnostic Ultrasound System | October 26, 2023 |