FDAFDA · Food and drugs·Recall number Z-1800-2025
Product Name: Ingenia 3.0T CX; Model Number: 781271;
Published May 28, 2025 · Recall initiated: May 13, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips North America Llc
- Distributor
- Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.
- Lot
- Model Number: 781271; UDI-DI: 00884838068452; Serial Numbers: 78012, 78016, 78017, 78018, 78025, 78028, 78033, 78035, 78039, 78042, 78045, 78050, 78053, 78060, 78062, 78082, 78095, 78100, 78112, 78122, 78123, 78133, 78147, 78148, 78155, 78175, 78197, 78199, 78201, 78202, 78217, 78229, 78239, 78259, 78260, 78286, 78287;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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