FDA-Device2026-09-30Class IIPROCESSING DEFECT
Philips Evolution upgrade MRI systems recalled for software crash risk during image reconstruction
What this means
Certain Philips Evolution upgrade 1.5T and 3.0T MRI systems contain a software issue that can cause an examination to terminate unexpectedly during image reconstruction. This happens when scan parameters are manually adjusted in a way that exceeds the system's available memory.
- Check if your facility operates an affected Philips Evolution upgrade MRI system using the model and serial numbers listed in the recall notice.
- Contact Philips for a software update or corrective instructions.
- Do not manually adjust scan parameters beyond system memory capacity until the issue is resolved.
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
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;
Affected count
91
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
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);
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3235-2026More Philips recalls
- FDA-Device2026-09-30Philips Ingenia 3.0T MRI systems recalled for software image reconstruction failure
- FDA-Device2026-09-30Philips SmartPath MRI software recalled for exam termination risk
- FDA-Device2026-09-30Philips Achieva 1.5T MRI systems recalled for software issue causing exam termination
- FDA-Device2026-09-30Philips Ingenia Ambition MRI systems recalled for software crash during image processing
- FDA-Device2026-09-30Philips Intera 1.5T MRI systems recalled for software examination termination risk
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