Philips North America Llc: Achieva 1.5T Conversion

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: 68 units Lot/code info: Product No. 781283 & 781346; UDI-DI: (01)00884838009806(21)39001, (01)00884838009806(21)39027, (01)00884838009806(21)39028, (01)00884838009806(21)39030, (01)00884838009806(21)39032, (01)00884838009806(21)39039, (01)00884838009806(21)39053, (01)00884838009806(21)39059, (01)00884838009806(21)39061, (01)00884838009806(21)39062, (01)00884838009806(21)39064, (01)00884838009806(21)39065, (01)00884838009806(21)39066, (01)00884838009806(21)39067, (01)00884838009806(21)39072, (01)00884838009806(21)39073, (01)00884838009806(21)39074, (01)00884838009806(21)39075, (01)00884838009806(21)39078, (01)00884838009806(21)39080, (01)00884838009806(21)39081, (01)00884838009806(21)39082, (01)00884838009806(21)39083, (01)00884838009806(21)39084, (01)00884838009806(21)39086, (01)00884838009806(21)39088, (01)00884838009806(21)39090, (01)00884838009806(21)39091, (01)00884838009806(21)39093, (01)00884838009806(21)39094, (01)00884838009806(21)39095, (01)00884838009806(21)39097, (01)00884838009806(21)39098, (01)00884838009806(21)39100, (01)00884838009806(21)39102, (01)00884838009806(21)39105, (01)00884838009806(21)39106, (01)00884838009806(21)39107, (01)00884838068469(21)5243, (01)00884838068469(21)5547, (01)00884838068469(21)8020, (01)00884838068469(21)8276, (01)00884838068469(21)8289, (01)00884838068469(21)8361, (01)00884838068469(21)8367, (01)00884838068469(21)8371, (01)00884838068469(21)8415, (01)00884838068469(21)8714, (01)00884838068469(21)8727, (01)00884838068469(21)8740, (01)00884838068469(21)878

UPC codes

00884838009806, 00884838068469

Source

Official record: FDA (Device enforcement) ↗

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