Recall Z-2386-2025— Philips Ultrasound, Inc
Class III · Ongoing
Class III FDA medical device recall by Philips Ultrasound, Inc, initiated 2025-07-03. It names 2 FDA 510(k) clearances: K250030, K231190. Product: mL26-8 Transducer Probe. 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
- 2025-07-03
- Firm location
- Reedsville, PA, United States
510(k) clearances named in this recall
2 on FDA's record- K250030 — Flash Ultrasound System 5100 Point of Care
- K231190 — EPIQ Series 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
mL26-8 Transducer Probe
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.