Evolution upgrade 1.5T and Evolution upgrade 3.0T Recall: Software Issue
Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782117 (3.0T), 4. 782143 (3.0T);
Why was Evolution upgrade 1.5T and Evolution upgrade 3.0T recalled?
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?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
1. Model Numbers (REF): 782116 (1.5T); UDI-DI: 884838099722; Serial Numbers: 41130, 70284, 41491, 41196, 41520, 70068, 41024, 41025, 41051, 41139, 41144, 41286, 41327, 41349, 41424, 41432, 41433, 70099, 70202, 81073, 41344, 41229, 41457, 41497, 41413, 41080, 41527, 70205, 70589, 81021, 41179, 41189, 70949; 2. Model Numbers (REF): 782148 (1.5T); UDI-DI: 884838108714; Serial Numbers: 41523, 70630, 70966, 84102, 84473, 84825, 41031, 41043, 41085, 41284, 41392, 41553, 70596, 81006, 70644, 41488, 41534, 70454, 41167, 41375, 41446, 70652, 41011, 70590, 70195, 84628; 3. Model Numbers (REF): 782117 (3.0T); UDI-DI: 884838099739; Serial Numbers: 42246, 85713, 42029, 71774, 85668, 85680, 85685, 85694, 42023, 42024, 42078, 42217, 42402, 71348, 71044, 85698, 85146, 42003, 85663, 85677; 4. Model Numbers (REF): 782143 (3.0T); UDI-DI: N/A; Serial Numbers: 71815, 42440, 71389, 85688, 85690, 85649, 42193, 42366, 85683, 85697, 85701, 85708;
- Product
- Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782117 (3.0T), 4. 782143 (3.0T);
- Recalling firm
- Philips North America Llc
- Quantity
- 91
- 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;
- Recall started
- August 21, 2026
- Report date
- September 30, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)