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Philips Ultrasound, LLC recalls Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Recalled December 10, 2025 · FDA recall Z-0883-2026 · Philips Ultrasound
Hazard
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining. · FDA Class II
Units
4,819 systems
Sold at
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.
Description
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
Product
Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Manufacturer(s)
Philips Ultrasound, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →