Philips North America: Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;

Hazard

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.

Details from the source

Reason for recall: 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. 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, Finl Quantity: 460 units Lot/code info: 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, 3427

UPC codes

00884838004139

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.