FDA-Device2025-12-10Class II
Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Philips Ultrasound, LLC
Hazard
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
Sold states
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.
Affected count
4,819 systems
Manufactured in
22100 Bothell Everett Hwy, Bothell, WA, United States
Products
Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0883-2026Don't want to check this manually?
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