Philips Ultrasound, LLC: Device Recall
Recall #Z-0883-2026 · 10/31/2025
Recall Details
- Recall Number
- Z-0883-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Philips Ultrasound, LLC
- Status
- Ongoing
- Date Initiated
- 10/31/2025
- Location
- Bothell, WA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,819 systems
Reason for Recall
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
Product Description
Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Distribution Pattern
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.