Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,

FDA Recall Z-0883-2026 · Posted 2025-12-04

Recalling FirmPhilips Ultrasound, LLC
Recall StatusOpen, Classified
Product CodeIYN
Date Initiated2025-10-31
Product Quantity4,819 systems

Reason for Recall

Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.

Firm Action

On November 1, 2025, Philips issues an Urgent Medical Device Recall (Correction) Notification to affected consignees. Phillips ask consignees to take the following actions: 1. Utilize an Android based device with your Lumify system. 2. Lightning port devices are not affected and may continue to be used as normal. 3. If you use an 05 based device, do not update your OS device to software version lax. 4. Turn off 05 auto-updates on USB host devices for Lumify by following the below steps: 5. Place this Notice with the documentation of the affected Ultrasound system(s); ensure the notice is in a place likely to be viewed by device operators. 6. Circulate this Notice to all users of the affected device(s) so that they are aware of the issue. 7. Complete the Acknowledgment form indicating you have read and understand the recall.

Root Cause

Software design

Distribution Pattern

Worldwide US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR and the countries of Argentina, Armenia, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Dominican Rep, Ecuador, El Salvador, Estonia, France, Germany, Greece, Guatemala, Honduras , Hungary, Iceland, India, Indonesia, Israel, Italy, Jordan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Singapore, Slovakia, South Africa, South Korea, Spain, St. Pier/Miquel., Sweden, Switzerland, Taiwan, Thailand, Trinidad/Tobago, Tunisia, T¿rkiye, United Kingdom, Uruguay, Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025-05-15K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025-05-08K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2023-10-26K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2023-05-04K203406Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2021-02-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑