FDA-Device2026-09-30Class IIPROCESSING DEFECT
Philips Ingenia 3.0T MRI systems recalled for software image reconstruction failure
What this means
A software issue in certain Philips Ingenia 3.0T and 3.0T CX MRI machines can cause the system to stop abruptly during image reconstruction if scan parameters are manually adjusted in a way that exceeds available system memory. This interruption could require the scan to be repeated, delaying patient imaging.
- Contact Philips technical support if your facility operates an affected Ingenia 3.0T or 3.0T CX model to confirm your serial number and discuss available options.
- Avoid manually adjusting scan parameters beyond normal limits until a corrective software update is installed.
- Check for a software patch or firmware update from Philips to resolve the memory issue.
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
1447
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3. 782103(3.0T), 4. 781271(3.0T CX), 5. 782105(3.0T CX);
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3238-2026More Philips recalls
- 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
- FDA-Device2026-09-30Philips Evolution upgrade MRI systems recalled for software crash risk during image reconstruction
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