Philips Ultrasound, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 123
- 510(k) Clearances
- 70
- 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-2382-2025 | Class III | L9-3 Transducer Probe | July 3, 2025 |
| Z-2358-2025 | Class III | C8-4v Transducer Probe | July 3, 2025 |
| Z-2348-2025 | Class III | 7.5MHZ Endo Transducer Probe | July 3, 2025 |
| Z-2411-2025 | Class III | X7-2 Transducer Probe | July 3, 2025 |
| Z-2412-2025 | Class III | X7-2t Transducer Probe | July 3, 2025 |
| Z-2381-2025 | Class III | L8-4 Transducer Probe | July 3, 2025 |
| Z-2361-2025 | Class III | C9-3io Transducer Probe | July 3, 2025 |
| Z-2367-2025 | Class III | D2TCD Transducer Probe | July 3, 2025 |
| Z-2371-2025 | Class III | L11-3 Transducer Probe | July 3, 2025 |
| Z-2389-2025 | Class III | S12-4 Transducer Probe | July 3, 2025 |
| Z-2399-2025 | Class III | S9-2 Transducer Probe | July 3, 2025 |
| Z-2355-2025 | Class III | C6-2 Transducer Probe | July 3, 2025 |
| Z-2410-2025 | Class III | X6-1 Transducer Probe | July 3, 2025 |
| Z-2362-2025 | Class III | C9-3v Transducer Probe | July 3, 2025 |
| Z-2404-2025 | Class III | V9-2 Transducer Probe | July 3, 2025 |
| Z-2357-2025 | Class III | C8-4v Transducer Probe | July 3, 2025 |
| Z-2395-2025 | Class III | S7-3t Transducer Probe | July 3, 2025 |
| Z-2393-2025 | Class III | S4-2 Transducer Probe | July 3, 2025 |
| Z-2390-2025 | Class III | S3-1 Transducer Probe | July 3, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| 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 |
| K231190 | EPIQ Series Diagnostic Ultrasound System | May 12, 2023 |