United StatesPhilips Ultrasound, LLC is recalling Lumify Diagnostic Ultrasound System models 795005, 795161, and 989605449841 (UDI: 700884838103405, 00884838120266, 00884838064713; multiple serial numbers) with 4,819 systems distributed worldwide. The devices may have compatibility issues with Apple devices running iOS 18 that can cause a failure to perform live imaging.
What's being recalled
Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Recalling firm: Philips Ultrasound, LLC, Bothell, WA, United States.
How to identify it
UDI:700884838103405, 00884838120266, 00884838064713, 00884838108455 / Serial Numbers: USD21L1900 US122L0603 USD21L1901 USD21L1722 US122L1176 USD21L1720 US122L1175 US122L1186 US122L0415 US122L1174 USD21L1587 USD21L1586 USD21L1416 USD21L2073 USD21L1589 USD21L1721 US122L1177 US122L1305 US122L0996 USD21L1588 US122L1190 US122L1183 US122L0416 US122L1671 US122L0523 USD21L1719 US122L0522 US122L1048 USD21L1417 US122L1856 US122L1854 US122L1852 US122L1376 US122L1310 US122L0040 US122L1289 US122L1673 US122L0602 USD21L1590 US122L1307 USD21L2052 US122L1311 US122L0038 US122L1309 USO21L0079 US122L1855 USO21L0048 US921L1762 USO21L0046 USO21L0017 USO21L1376 US921L1485 USO21L0045 US921L1331 US921L1694 USO21L0038 USO21L0039 US921L1761 USO21L0040 US921L1760 US921L1759 US921L1695 US921L1609 USO21L0044 USO21L0078 USO21L0050 USO21L0015 US921L1610 USO21L0003 USO21L0043 US921L1484 USO21L1495 USO21L0093 USO21L1374 USO21L1373 USO21L1755 USO21L0081 USO21L0119 USO21L1667 USO21L0579 USO21L0083 USD21L2046 USO21L1375 USO21L0042 US921L1330 USO21L0041 US921L1693 USO21L0036 USO21L1753 USO21L0049 USO21L0037 US921L1696 USO21L0016 USO21L0047 USO21L0764 USO21L0080 USD21L2054 USD21L0049 USD21L0036 USD21L0037 USO21L0082 USD21L2049 USD21L2055 USD21L2051 USD21L2047 USD21L2239 USD21L0055 USD21L2153 USD21L0068 US122L0037 USD21L0039 USD21L0053 USD21L0056 US622L0962 USD21L0040 USD21L2048 USO21L0578 USD21L0050 USD21L0051 USD21L0052 USD21L0066 USD21L0704 USD21L0054 USD21L0524 US821L0816 US821L0583 US821L0586 US821L0246 US821L0585 US821L0582 US821L0580 US821L0347 US821L0587 US821L0581 US821L0584 US821L0420 US821L0473 US821L0101 US821L0099 US821L0100 US821L0098 US621L2293 US621L2144 US721L0342 US621L2051 US621L1995 US621L2053 US621L2050 US721L0807 US621L2054 US621L2049 US721L0530 US721L0406 US621L2057 US721L0529 US621L1997 US721L0404 US721L0528 US621L2056 US721L0395 US621L2058 US721L0803 US721L0397 US721L0804 US621L2055 US621L2052 US621L1996 US721L0808 US721L0403 US721L0396 US721L0805 US721L0398 US721L0405…
The hazard
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)