Recall Z-1625-2026— Philips Ultrasound, Inc
Class III · Ongoing
Class III FDA medical device recall by Philips Ultrasound, Inc, initiated 2025-09-05. It names 5 FDA 510(k) clearances: K192226, K162549, K153480 and 2 more. Product: Philips S4-1 Ultrasound Transducer. Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field..
- Recalling firm
- Philips Ultrasound, Inc
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2025-09-05
- Firm location
- Reedsville, PA, United States
510(k) clearances named in this recall
5 on FDA's record- K192226 — Lumify Diagnostic Ultrasound System
- K162549 — Lumify Ultrasound System
- K153480 — ClearVue850 Diagnostic Ultrasound System
- K120321 — CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM
- K030455 — BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Philips S4-1 Ultrasound Transducer
Reason for recall
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Data sourced from openFDA. This site is unofficial and independent of the FDA.