FDAFDA · Food and drugs·Recall number Z-3240-2026
Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT Nova (781175), 4. Intera 1.5T Achieva Nova (781172), 5. Intera 1.5T Achieva Nova-Dual (781173), 6. Intera 1.5T Omni/Stellar (781104), 7. Intera Achieva 1.5T Pulsar (781171);
Published September 30, 2026 · Recall initiated: August 21, 2026
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
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips North America Llc
- Distributor
- Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia;
- Lot
- 1. Intera 1.5T Model Numbers (REF): 781195; UDI-DI: N/A; Serial Numbers: 18774, 18781, 18951, 18958, 18962, 18971, 20431, 18898, 20429, 18669, 18981, 18982, 18734, 18763, 20427, 18842, 18654, 18878, 18566, 18618, 18752, 20409, 18748, 18743, 18657, 20424, 18755, 18908, 18501, 18646, 18768, 18516, 18554, 18616, 18723, 18725, 18784; 2. Intera 1.5T; Model Numbers (REF): 781295; UDI-DI: N/A; Serial Numbers: 30138, 30297, 30314, 30210, 30137, 30173, 30179, 30104, 30105, 30290, 30208, 30051, 30035, 30143, 30109, 30063, 30237, 30135; 3. Intera 1.5T Achieva IT Nova; Model Numbers (REF): (781175); UDI-DI: N/A; Serial Number: 15003; 4. Intera 1.5T Achieva Nova; Model Numbers (REF): 781172; UDI-DI: N/A; Serial Numbers: 12105, 12049, 12079, 12001, 12086, 12099, 12046, 12057, 12081, 12075, 12078, 12106; 5. Intera 1.5T Achieva Nova-Dual; Model Numbers (REF): 781173; UDI-DI: N/A; Serial Numbers: 13006, 13017, 13058, 13012, 13048, 13049; 6. Intera 1.5T Omni/Stellar; Model Numbers (REF): 781104; UDI-DI: N/A; Serial Number: 10403; 7. Intera Achieva 1.5T Pulsar; Model Numbers (REF): 781171; UDI-DI: 884838088108; Serial Numbers: 11044, 11009, 11029, 11043, 11040, 11039, 11090;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Related recalls
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- FDAIngenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3. 782103(3.0T), 4.…September 30, 2026
- FDAIngenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T), 2. 781341(1.5T), 3. …September 30, 2026
- FDAAchieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers (REF): 1. 781196 (Achie…September 30, 2026
- FDAIngenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137(S), 4. 7…September 30, 2026
- FDAMR 5300 Model Number (REF): 1. 782110, 2. 782152;September 30, 2026
- FDAMR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade);September 30, 2026
- FDAIngenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S),…September 30, 2026
Questions about this recall
Was Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT Nova (781175), 4. Intera 1.5T Achieva Nova (781172), 5. Intera 1.5T Achieva Nova-Dual (781173), 6. Intera 1.5T Omni/Stellar (781104), 7. Intera Achieva 1.5T Pulsar (781171); recalled?
Yes. FDA published recall Z-3240-2026 on September 30, 2026. Reported hazard: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
What should I do if I have this product?
Voluntary: Firm initiated · Letter
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