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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Lumify Ultrasound Systems Recalled for Failed Imaging on iOS 18

Agency Publication Date: December 4, 2025
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Summary

Philips Ultrasound, LLC has recalled 4,819 Lumify Diagnostic Ultrasound Systems because they are incompatible with Apple devices running iOS 18. This software issue causes the system to fail when trying to perform live imaging, rendering the diagnostic tool unusable with updated mobile devices. The recall affects models 795005, 795161, and 989605449841. Users should stop using these systems with iOS 18 devices and contact the manufacturer to arrange for a software correction or device replacement.

Risk

The failure to perform live imaging prevents medical professionals from seeing real-time scans, which can lead to significant delays in clinical diagnosis or medical treatment. In emergency or critical care situations, the inability to use the ultrasound could result in serious patient harm due to the loss of diagnostic capabilities.

What You Should Do

  1. This recall affects Philips Lumify Diagnostic Ultrasound System models 795005, 795161, and 989605449841 when used with Apple mobile devices running iOS 18.
  2. Identify if your system is part of the recall by checking the model number and serial number printed on the device label. See the Affected Products section below for the full list of affected serial numbers.
  3. Stop using the recalled ultrasound system with any Apple device that has been updated to iOS 18.
  4. Contact Philips Ultrasound, LLC or your authorized distributor to arrange for a system correction, software update, or product replacement.
  5. Call the FDA at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this safety notice.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Lumify Diagnostic Ultrasound System
Model / REF:
795005
795161
989605449841
Serial Numbers (4182):
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
UDI:
700884838103405
00884838120266
00884838064713
00884838108455

Quantity affected: 4,819 systems.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97843
Status: Active
Manufacturer: Philips Ultrasound, LLC
Sold By: Authorized Philips Medical Distributors; Healthcare Equipment Dealers
Manufactured In: United States
Units Affected: 4,819 systems
Distributed To: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.