FDA-Device2026-09-30Class IIPROCESSING DEFECT
Philips Achieva 3.0T MRI scanner recalled for software crash risk during image reconstruction
What this means
A software issue in certain Philips Achieva 3.0T MRI scanners can cause an examination to terminate unexpectedly during image reconstruction if scan parameters are manually adjusted in a way that exceeds the system's available memory. This affects specific serial numbers across five model variants distributed worldwide.
- Contact Philips if you operate an affected Achieva 3.0T MRI scanner (check your model and serial number against the recall notice)
- Avoid manually adjusting scan parameters beyond normal operating limits until a software fix is applied
- Monitor your system for termination errors during image reconstruction
- Follow Philips guidance on a corrective software update or workaround
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
210
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3233-2026More 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
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.