Device recall
Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;
- Recall number
- Z-3234-2026
- Event id
- 99769
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Philips North America Llc
- Report date
- Sep 30, 2026
- Posted
- Sep 18, 2026
- Initiated
- Aug 21, 2026
- Center classification date
- Sep 18, 2026
- Product code
- LNH
- Device type
- System, Nuclear Magnetic Resonance Imaging
- Reason
- 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.
- Root cause
- Software design
- Quantity
- 15
- Code info
- 1. Model Numbers (REF): 781153; UDI-DI: N/A; Serial Numbers: 23035, 23003, 23021, 23028; 2. Model Numbers (REF): 781253; UDI-DI: N/A; Serial Numbers: 35028, 35068, 35083, 35074, 35049, 35004, 35006, 35011, 35015, 35050, 35076;
- 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;
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K052078
- Location
- Cambridge, MA, United States