Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Reported: December 10, 2025 Initiated: October 31, 2025 #Z-0883-2026
Product Description
Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Reason for Recall
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
Details
- Recalling Firm
- Philips Ultrasound, LLC
- Units Affected
- 4,819 systems
- Distribution
- 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.
- Location
- Bothell, WA
Frequently Asked Questions
What product was recalled? ▼
Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,. Recalled by Philips Ultrasound, LLC. Units affected: 4,819 systems.
Why was this product recalled? ▼
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 10, 2025. Severity: Moderate. Recall number: Z-0883-2026.
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