Recall Z-0883-2026— Philips Ultrasound, LLC
Class II · Ongoing
Class II FDA medical device recall by Philips Ultrasound, LLC, initiated 2025-10-31. It names 5 FDA 510(k) clearances: K242519, K242670, K232500 and 2 more. Product: Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,. Reason: Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining..
- Recalling firm
- Philips Ultrasound, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-10-31
- Firm location
- Bothell, WA, United States
510(k) clearances named in this recall
5 on FDA's record- K242519 — Lumify Diagnostic Ultrasound System
- K242670 — Lumify Diagnostic Ultrasound System
- K232500 — Lumify Diagnostic Ultrasound System
- K223771 — Lumify Diagnostic Ultrasound System
- K203406 — Lumify 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
Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Reason for recall
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
Data sourced from openFDA. This site is unofficial and independent of the FDA.