FDA-Device2026-09-30Class IIPROCESSING DEFECT
Philips MR 5300 MRI scanner recalled for software crash during image reconstruction
What this means
A software issue in certain Philips MR 5300 MRI scanners can cause the system to shut down unexpectedly during image reconstruction if scan parameters are manually adjusted in ways that exceed the scanner's available memory. This interruption stops the examination and may require the scan to be restarted.
- Contact Philips if you operate an affected MR 5300 scanner to receive a software update or patch.
- Check your device serial number against the FDA recall notice to confirm if your scanner is affected.
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
All ages
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
611
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
MR 5300 Model Number (REF): 1. 782110, 2. 782152;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3241-2026More 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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