Philips North America Llc recalls Name

Recalling company

Philips North America Llc

Product

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);

Reason

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Aug 21, 2026

Reported

Sep 30, 2026

Distribution

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;

Status

Ongoing

Quantity

82

Lot / codes

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;

Company location

Cambridge, MA

Recall type

Voluntary: Firm initiated

Recall number

Z-3240-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-3240-2026 in the FDA Enforcement Report. Also see FDA recall press releases.