FDA-Device2025-12-10Class IIPROCESSING DEFECT
Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Hazard
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
Intended for
Adults
Illnesses reported
None reported
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-0883-2026Want us to check the next one for you?
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