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
    • 795005
    • 795161
    • 989605449841
Lot codes and dates
  • UDI
    • 700884838103405
    • 00884838120266
    • 00884838064713
    • 00884838108455 /
  • Serial Numbers

    2,956 of 2,956 codes

    • 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
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:35 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.