Reported Dec 10, 2025 · Ongoing
Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Philips Ultrasound, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Ultrasound, LLC · 22100 Bothell Everett Hwy · Bothell, WA · 98021-8431
Is this the product you have?
- Lumify
- Diagnostic Ultrasound System models
795005795161989605449841
- Lot codes and dates
- UDI
700884838103405008848381202660088483806471300884838108455 /
- Serial Numbers
2,956 of 2,956 codes
USD21L1900US122L0603USD21L1901USD21L1722US122L1176USD21L1720US122L1175US122L1186US122L0415US122L1174USD21L1587USD21L1586USD21L1416USD21L2073USD21L1589USD21L1721US122L1177US122L1305US122L0996USD21L1588US122L1190US122L1183US122L0416US122L1671US122L0523USD21L1719US122L0522US122L1048USD21L1417US122L1856US122L1854US122L1852US122L1376US122L1310US122L0040US122L1289US122L1673US122L0602USD21L1590US122L1307USD21L2052US122L1311US122L0038US122L1309USO21L0079US122L1855USO21L0048US921L1762USO21L0046USO21L0017USO21L1376US921L1485USO21L0045US921L1331US921L1694USO21L0038USO21L0039US921L1761USO21L0040US921L1760
- UDI
- Amount recalled
- 4,819 systems
Where it was sold
Why it was recalled
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
This product could cause temporary or reversible health problems — stop using it.
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