Philips North America Llc: Achieva 1.5T

Hazard

Potential component failure in the Gradient Coil could product smoke and/or fire.

Details from the source

Reason for recall: Potential component failure in the Gradient Coil could product smoke and/or fire. Distribution: Domestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Libya, Luxembourg, Malaysia, Malta Quantity: 520 units Lot/code info: Product No. 781178, 781196, 781296, & 781343; UDI-DI: (01)00884838004108(21)8524, (01)00884838004108(21)32039, (01)00884838004108(21)32052, (01)00884838004108(21)32083, (01)00884838004108(21)32087, (01)00884838004108(21)32097, (01)00884838004108(21)32103, (01)00884838004108(21)32118, (01)00884838004108(21)32123, (01)00884838004108(21)32150, (01)00884838004108(21)32153, (01)00884838004108(21)32154, (01)00884838004108(21)32186, (01)00884838004108(21)32223, (01)00884838004108(21)32226, (01)00884838004108(21)32228, (01)00884838004108(21)32230, (01)00884838004108(21)32231, (01)00884838004108(21)32243, (01)00884838004108(21)32247, (01)00884838004108(21)32255, (01)00884838004108(21)32265, (01)00884838004108(21)32288, (01)00884838004108(21)32289, (01)00884838004108(21)32306, (01)00884838004108(21)32350, (01)00884838004108(21)32375, (01)00884838004108(21)32376, (01)00884838004108(21)32385, (01)00884838004108(21)32387, (01)00884838004108(21)32390, (01)00884838004108(21)32392, (01)00884838004108(21)32413, (01)00884838004108(21)32435, (01)00884838004108(21)32439, (01)00884838004108(21)32452, (01)00884838004108(21)32459, (01)00884838004108(21)32463, (01)00884838004108(21)32474, (01)00884838004108(21)32505, (01)00884838004108(21)32531, (01)00884838004108(21)32533, (01)00884838004108(21)32537, (01)00884838004108(21)32567, (01)00884838004108(21)32584, (01)00884838004108(21)32591, (01)00884838004108(21)32595, (01)00884838004108(21)32603, (01)00884838004108(21)32608, (01)00884838004108(21)3261

UPC codes

00884838004108, 00884838055292

Source

Official record: FDA (Device enforcement) ↗

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