Recall archive / FDA device enforcement

Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345; — FDA record Z-2200-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jun 30, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;
Reason: 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.
Classification: Class II
Recalling firm: Philips North America
Quantity: 460 units
Agency-reported status: Ongoing
Source record identifier: Z-2200-2025

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345; UDI-DI: (1) None, (2) None, (3) 00884838004139, (4) None, (5) None; Serial Numbers: (1) 17008, 17011, 17017, 17030, 17035, 17038, 17039, 17043, 17049, 17051, 17056, 17061, 17072, 17075, 17079, 17093, 17094, 17099, 17114, 17130, 17134, 17139, 17142, 17144, 17146, 17147, 17149, 17161, 17167, 17168, 17170, 17171, 17178, 17179, 17182, 17183, 17185, 17187, 17189, 17216, 17217, 17226, 17233, 17234, 17235, 17243, 17251, 17256, 17270, 17279, 17295, 17296, 17304, 17316, 17319, 17324, 17334, 17347, 17349, 17358, 17362, 17365, 17374, 17379, 17384, 17392, 17393, 17393, 17402, 17404, 17414, 17418, 17426, 17427, 17431, 17432, 17443, 17445, 17446, 17448, 17450, 17452, 17453, 17456, 17469, 17471, 17494, 17497, 17500, 17523, 17535, 17558, 17561, 17596, 17599, 17607, 24007, 24009, 24010, 24019, 24037, 24038, 24049, 24050, 24053, 24056, 24059, 24060, 24066, 24068, 24070, 24078, 24079, 24081, 24089, 24091, 24096, 24097, 24099, 24100, 24107, 24114, 24116, 24120, 24125, 24130, 24131, 24138, 24154, 34148, (2) 24115, 34002, 34011, 34020, 34028, 34029, 34030, 34033, 34034, 34038, 34043, 34065, 34066, 34071, 34073, 34074, 34077, 34082, 34086, 34095, 34106, 34109, 34113, 34115, 34118, 34120, 34123, 34135, 34138, 34139, 34140, 34144, 34159, 34160, 34165, 34200, 34201, 34203, 34207, 34213, 34220, 34225, 34230, 34231, 34232, 34234, 34237, 34239, 34241, 34242, 34247, 34253, 34254, 34255, 34256, 34258, 34263, 34264, 34268, 34270, 34271, 34272, 34273, 34274, 34275, 34276, 34281, 34282, 34285, 34286, 34287, 34288, 34289, 34290, 34291, 34293, 34294, 34295, 34297, 34298, 34299, 34300, 34301, 34305, 34306, 34309, 34311, 73012, (3) 38002, 38003, 38007, 38012, 38017, 38018, 38021, 38022, 38033, 38034, 38043, 38044, 38047, 38054, 38055, 38056, 38057, 38059, 38060, 38061, 38064, 38069, 38072, 38079, 38085, 38086, 38087, 38090, 38091, 38093, 38095, 38098, 38099, 38103, 38104, 38108, 38112, 38115, 38130, 38133, 38137, 38139, 38140, 38141, 38143, 38144, 38145, 38150, 38151, 38152, 38157, 38158, 38160, 38167, 38169, 38171, 38173, 38174, 38181, 38185, 38186, 38187, 38188, 38190, 38191, 38194, 38196, 38200, 38206, 38207, 38209, 38210, 38212, 38215, 38216, 38220, 38223, 38227, 38228, 38229, 38231, 38232, 38233, 38236, 38238, 38240, 38241, 38245, 38246, 38247, 38248, 38249, 38251, 38252, 38253, 38254, 38255, 38256, 38257, 38258, 38260, 38261, 38262, 38264, 38265, 38266, 38267, 38268, 38269, 38270, 38271, 38272, 38273, 38274, 38276, 38278, 38279, 38280, 38282, 38283, 38284, 38287, 38288, 38291, 38292, 38293, 38295, 38296, 38297, 38298, 38299, 38302, 38303, 38304, 38307, 38312, 38314, 38315, 38318, 38319, 38320, 38321, 38322, 38323, 38324, 38326, 38327, 38328, 38329, 38330, 38331, 38332, 38335, 38337, 38338, 38339, 38340, 38341, 38343, 38344, 38345, 38346, 38347, 38349, 38351, 38355, 38358, 38359, 38360, 38361, 38363, 38367, 38368, 38370, 38372, 38401, 38402, 38405, 38407, 38408, 38410, 38412, 38414, 38415, 38420, 38421, 38423, 38424, 38425, 38426, 38427, 38429, 38430, 38431, 38432, 38433, 38436, 38437, 38438, 38439, 38441, 38442, 38443, 38445, 38447, 38448, 38450, 38453, 38454, 38456, 38457, 38458, 382320, (4) 73003, 73005, 73006, 73008, 73009, 73010, (5) 74001, 74005, 74007, 74009, 74010, 74020, 74021, 74026, 74027, 74029, 74030, 74032, 74033, 74034, 74035, 74037, 74039, 74041, 74044, 74046, 74047, 74048, 74052;

Label field

Details supplied by the agency

Lot, code or applicability

Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345; UDI-DI: (1) None, (2) None, (3) 00884838004139, (4) None, (5) None; Serial Numbers: (1) 17008, 17011, 17017, 17030, 17035, 17038, 17039, 17043, 17049, 17051, 17056, 17061, 17072, 17075, 17079, 17093, 17094, 17099, 17114, 17130, 17134, 17139, 17142, 17144, 17146, 17147, 17149, 17161, 17167, 17168, 17170, 17171, 17178, 17179, 17182, 17183, 17185, 17187, 17189, 17216, 17217, 17226, 17233, 17234, 17235, 17243, 17251, 17256, 17270, 17279, 17295, 17296, 17304, 17316, 17319, 17324, 17334, 17347, 17349, 17358, 17362, 17365, 17374, 17379, 17384, 17392, 17393, 17393, 17402, 17404, 17414, 17418, 17426, 17427, 17431, 17432, 17443, 17445, 17446, 17448, 17450, 17452, 17453, 17456, 17469, 17471, 17494, 17497, 17500, 17523, 17535, 17558, 17561, 17596, 17599, 17607, 24007, 24009, 24010, 24019, 24037, 24038, 24049, 24050, 24053, 24056, 24059, 24060, 24066, 24068, 24070, 24078, 24079, 24081, 24089, 24091, 24096, 24097, 24099, 24100, 24107, 24114, 24116, 24120, 24125, 24130, 24131, 24138, 24154, 34148, (2) 24115, 34002, 34011, 34020, 34028, 34029, 34030, 34033, 34034, 34038, 34043, 34065, 34066, 34071, 34073, 34074, 34077, 34082, 34086, 34095, 34106, 34109, 34113, 34115, 34118, 34120, 34123, 34135, 34138, 34139, 34140, 34144, 34159, 34160, 34165, 34200, 34201, 34203, 34207, 34213, 34220, 34225, 34230, 34231, 34232, 34234, 34237, 34239, 34241, 34242, 34247, 34253, 34254, 34255, 34256, 34258, 34263, 34264, 34268, 34270, 34271, 34272, 34273, 34274, 34275, 34276, 34281, 34282, 34285, 34286, 34287, 34288, 34289, 34290, 34291, 34293, 34294, 34295, 34297, 34298, 34299, 34300, 34301, 34305, 34306, 34309, 34311, 73012, (3) 38002, 38003, 38007, 38012, 38017, 38018, 38021, 38022, 38033, 38034, 38043, 38044, 38047, 38054, 38055, 38056, 38057, 38059, 38060, 38061, 38064, 38069, 38072, 38079, 38085, 38086, 38087, 38090, 38091, 38093, 38095, 38098, 38099, 38103, 38104, 38108, 38112, 38115, 38130, 38133, 38137, 38139, 38140, 38141, 38143, 38144, 38145, 38150, 38151, 38152, 38157, 38158, 38160, 38167, 38169, 38171, 38173, 38174, 38181, 38185, 38186, 38187, 38188, 38190, 38191, 38194, 38196, 38200, 38206, 38207, 38209, 38210, 38212, 38215, 38216, 38220, 38223, 38227, 38228, 38229, 38231, 38232, 38233, 38236, 38238, 38240, 38241, 38245, 38246, 38247, 38248, 38249, 38251, 38252, 38253, 38254, 38255, 38256, 38257, 38258, 38260, 38261, 38262, 38264, 38265, 38266, 38267, 38268, 38269, 38270, 38271, 38272, 38273, 38274, 38276, 38278, 38279, 38280, 38282, 38283, 38284, 38287, 38288, 38291, 38292, 38293, 38295, 38296, 38297, 38298, 38299, 38302, 38303, 38304, 38307, 38312, 38314, 38315, 38318, 38319, 38320, 38321, 38322, 38323, 38324, 38326, 38327, 38328, 38329, 38330, 38331, 38332, 38335, 38337, 38338, 38339, 38340, 38341, 38343, 38344, 38345, 38346, 38347, 38349, 38351, 38355, 38358, 38359, 38360, 38361, 38363, 38367, 38368, 38370, 38372, 38401, 38402, 38405, 38407, 38408, 38410, 38412, 38414, 38415, 38420, 38421, 38423, 38424, 38425, 38426, 38427, 38429, 38430, 38431, 38432, 38433, 38436, 38437, 38438, 38439, 38441, 38442, 38443, 38445, 38447, 38448, 38450, 38453, 38454, 38456, 38457, 38458, 382320, (4) 73003, 73005, 73006, 73008, 73009, 73010, (5) 74001, 74005, 74007, 74009, 74010, 74020, 74021, 74026, 74027, 74029, 74030, 74032, 74033, 74034, 74035, 74037, 74039, 74041, 74044, 74046, 74047, 74048, 74052;

Match all identifying details in the current notice. A brand name alone is not enough.

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 below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Aug 6, 2025
Recall initiation date: Jun 30, 2025
Center classification date: Jul 30, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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