Recall Z-2048-2025— Philips Ultrasound, Inc
Class II · Ongoing
Class II FDA medical device recall by Philips Ultrasound, Inc, initiated 2025-05-28. It names 5 FDA 510(k) clearances: K163120, K160807, K153480 and 2 more. Product: Philips 3D9-3v Transducer.. Reason: Ultrasound transducer devices were refurbished beyond their useful life..
- Recalling firm
- Philips Ultrasound, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-05-28
- Firm location
- Reedsville, PA, United States
510(k) clearances named in this recall
5 on FDA's record- 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
- K153480 — ClearVue850 Diagnostic Ultrasound System
- K081661 — HD15 DIAGNOSTIC ULTRASOUND SYSTEM
- K043535 — HD11 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 3D9-3v Transducer.
Reason for recall
Ultrasound transducer devices were refurbished beyond their useful life.
Data sourced from openFDA. This site is unofficial and independent of the FDA.