FDA Medical devices recall ·
Ingenia 1.5T S Model Number ( recall
- Recall number
- Z-2205-2025
- Date
- (initiated June 30, 2025)
- Company / brand
- Philips North America Llc
222 Jacobs St, Cambridge, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 136 units
- Hazard tags
- Fire
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Ingenia 1.5T S Model Number (REF): 781347;
Why was it recalled?
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number (REF): 781347; UDI-DI: 00884838068421; Serial Numbers: 81001, 81003, 81004, 81005, 81006, 81007, 81008, 81009, 81010, 81011, 81013, 81014, 81015, 81016, 81017, 81018, 81019, 81020, 81023, 81024, 81025, 81027, 81028, 81029, 81030, 81031, 81032, 81033, 81034, 81035, 81037, 81038, 81040, 81041, 81042, 81043, 81044, 81045, 81046, 81047, 81048, 81049, 81050, 81051, 81052, 81055, 81056, 81058, 81059, 81060, 81061, 81062, 81063, 81064, 81065, 81067, 81070, 81071, 81072, 81074, 81075, 81076, 81077, 81078, 81079, 81080, 81084, 81085, 81086, 81087, 81088, 81090, 81091, 81092, 81093, 81094, 81095, 81096, 81097, 81098, 81103, 81105, 81106, 81108, 81111, 81112, 81113, 81114, 81115, 81116, 81117, 81118, 81122, 81123, 81124, 81126, 81127, 81128, 81129, 81131, 81132, 81133, 81137, 81138, 81139, 81140, 81145, 81146, 81147, 81148, 81149, 81151, 81152, 81153, 81154, 81155, 81156, 81157, 81158, 81159, 81162, 81164, 81165, 81167, 81170, 81171, 81172, 81173, 81174, 81175, 81176, 81178, 81179, 81180, 81184, 81185;
Distribution
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Fiji, Finland, France, French Guiana, FrenchPolynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad,Tobago, Tunisia, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen, Zambia.
States: Georgia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2205-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.