Recall Z-1620-2026— 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: K123754, K093563, K081661 and 2 more. Product: Philips L12-5 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- K123754 — CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM
- K093563 — IU22 ULTRASOUND SYSTEM AND TRANSDUCERS
- K081661 — HD15 DIAGNOSTIC ULTRASOUND SYSTEM
- K043535 — HD11 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 L12-5 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.