Philips Ultrasound, Inc.
Philips Ultrasound, Inc. holds FDA 510(k) medical device clearances, first cleared 1985, most recent 2021, with 132 FDA device recalls on record.
Top product codes for Philips Ultrasound, Inc.
FDA recalls by Philips Ultrasound, Inc.
10 most recent of 132- Z-1623-2026 — Philips OMNI II TEE Ultrasound Transducer
- Z-1618-2026 — Philips 3D6-2 Ultrasound Transducer
- Z-1626-2026 — Philips S5-2 Ultrasound Transducer
- Z-1619-2026 — Philips C9-4 Ultrasound Transducer
- Z-1625-2026 — Philips S4-1 Ultrasound Transducer
- Z-1627-2026 — Philips X3-1 Ultrasound Transducer
- Z-1621-2026 — Philips L17-5 Ultrasound Transducer
- Z-1628-2026 — Philips X7-2 Ultrasound Transducer
- Z-1620-2026 — Philips L12-5 Ultrasound Transducer
- Z-1622-2026 — Philips Mini Multi TEE Ultrasound Transducer
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Philips Ultrasound, Inc.
- K212777 — Collaboration Live
- K203406 — Lumify Diagnostic Ultrasound System
- K200603 — AAA Model
- K201665 — Collaboration Live
- K202216 — EPIQ Series Diagnostic Ultrasound Systems
- K201053 — PercuNav Image Fusion and Interventional Navigation
- K201012 — EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System
- K200304 — EPIQ Diagnostic Ultrasound System
- K182857 — EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System
- K182529 — Xperius Ultrasound System
- K181485 — EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System
- K181264 — QLAB Advanced Quantification Software
- K170716 — PercuNav Image Fusion and Interventional Navigation
- K163120 — EPIQ 5 Diagnostic Ultrasound System +3 more
- K160807 — EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System
- K141369 — VISIQ DIAGNOSTIC ULTRA SOUND SYSTEM
- K140808 — Q-STATION
- K133833 — NUVIS DIAGNOSTIC ULTRASOUND SYSTEM
- K132304 — EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
- K132165 — QLAB QUANTIFICATION SOFTWARE
- K130499 — IU22 DIAGNOSTIC ULTRASOUND SYSTEM
- K123754 — CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM
- K121223 — QLAB WITH FHN AND VPQ PLUG-IN
- K111513 — CX50 DIAGNOSTIC ULTRASOUND SYSTEM
- K110414 — QLAB 8.1 QUANTIFICATION SOFTWARE
- K103815 — Q-STATION
- K093563 — IU22 ULTRASOUND SYSTEM AND TRANSDUCERS
- K091804 — CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS
- K081802 — CX50 DIAGNOSTIC ULTRASOUND SYSTEM
- K081661 — HD15 DIAGNOSTIC ULTRASOUND SYSTEM
- K070792 — QLAB QUANTIFICATION
- K062247 — HD11 DIAGNOSTIC ULTRASOUND SYSTEM
- K061396 — QLAB QUANTIFICATION SOFTWARE
- K043535 — HD11 DIAGNOSTIC ULTRASOUND SYSTEM
- K042540 — PHILIPS IU22 ULTRASOUND SYSTEM
- K034003 — HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM
- K030455 — BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM
- K023877 — Q LAB QUANTIFICATION SOFTWARE WITH STRAIN RATE QUANTIFICATION PLUG-IN
- K022303 — PHILIPS M2424 DIAGNOSTIC ULTRASOUND SYSTEM &PHILIPS 21315 DIAGNOSTIC ULTRASOUND TRANSDUCER
- K881028 — 7.5 MHZ ENDORECTAL PROBE
- K873937 — SDR 3500 (PHILIPS PLATINUM +)
- K872817 — 5 MHZ DOPPLER OUTRIGGER
- K864980 — 3MHZ ANNULAR ARRAY
- K870748 — 7.5 MHZ TRANSRECTAL (ENDORECTAL) PROBE
- K870709 — 7.5 MHZ ENDOVAGINAL PROBE
- K841048 — TRANSDUCER 4.OMHZ LA4011
Data sourced from openFDA. This site is unofficial and independent of the FDA.