Philips Ultrasound, Inc
FDA Regulatory Profile
Philips Ultrasound, Inc appears in FDA public data with 134 recalls, 75 510(k) clearances, 6 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0883-2026, Class II) was initiated on October 31, 2025. Its most recent 510(k) clearance was granted on June 29, 2026.
Summary
- Total Recalls
- 134
- 510(k) Clearances
- 75
- 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-1622-2026 | Class III | Philips Mini Multi TEE Ultrasound Transducer | September 5, 2025 |
| Z-1621-2026 | Class III | Philips L17-5 Ultrasound Transducer | September 5, 2025 |
| Z-1627-2026 | Class III | Philips X3-1 Ultrasound Transducer | September 5, 2025 |
| Z-1623-2026 | Class III | Philips OMNI II TEE Ultrasound Transducer | September 5, 2025 |
| Z-1626-2026 | Class III | Philips S5-2 Ultrasound Transducer | September 5, 2025 |
| Z-1628-2026 | Class III | Philips X7-2 Ultrasound Transducer | September 5, 2025 |
| Z-1624-2026 | Class III | Philips OMNI III TEE Ultrasound Transducer | September 5, 2025 |
| Z-1618-2026 | Class III | Philips 3D6-2 Ultrasound Transducer | September 5, 2025 |
| Z-1625-2026 | Class III | Philips S4-1 Ultrasound Transducer | September 5, 2025 |
| Z-1620-2026 | Class III | Philips L12-5 Ultrasound Transducer | September 5, 2025 |
| Z-1619-2026 | Class III | Philips C9-4 Ultrasound Transducer | September 5, 2025 |
| Z-2370-2025 | Class III | L10-4LAP Transducer Probe | July 3, 2025 |
| Z-2402-2025 | Class III | TRANSDUCER L12-5 Transducer Probe | July 3, 2025 |
| Z-2406-2025 | Class III | X11-4t Transducer Probe | July 3, 2025 |
| Z-2348-2025 | Class III | 7.5MHZ Endo Transducer Probe | July 3, 2025 |
| Z-2365-2025 | Class III | C9-5ec Transducer Probe | July 3, 2025 |
| Z-2390-2025 | Class III | S3-1 Transducer Probe | July 3, 2025 |
| Z-2411-2025 | Class III | X7-2 Transducer Probe | July 3, 2025 |
| Z-2382-2025 | Class III | L9-3 Transducer Probe | July 3, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K260667 | Alturion Series Diagnostic Ultrasound System | June 29, 2026 |
| K260680 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | May 27, 2026 |
| K260123 | EPIQ Series Diagnostic Ultrasound System | May 27, 2026 |
| K252558 | Lumify Diagnostic Ultrasound System | May 5, 2026 |
| 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 |