Recall Z-2053-2025— Philips Ultrasound, Inc
Class II · Ongoing
Class II FDA medical device recall by Philips Ultrasound, Inc, initiated 2025-05-28. It names 4 FDA 510(k) clearances: K202216, K182857, K181485 and 1 more. Product: Philips eL18-4 EMT 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
4 on FDA's record- K202216 — EPIQ Series Diagnostic Ultrasound Systems
- 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
- K181485 — EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System
- K172607 — Philips 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
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 eL18-4 EMT 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.