Recall Z-2392-2025— Philips Ultrasound, Inc
Class III · Ongoing
Class III FDA medical device recall by Philips Ultrasound, Inc, initiated 2025-07-03. It names 5 FDA 510(k) clearances: K223771, K203406, K201012 and 2 more. Product: S4-1 Lumify 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
5 on FDA's record- K223771 — Lumify Diagnostic Ultrasound System
- K203406 — Lumify Diagnostic Ultrasound System
- K201012 — EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System
- K192226 — Lumify Diagnostic Ultrasound System
- K162549 — Lumify 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
S4-1 Lumify 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.