Philips North America Llc: SmartPath to dStream for 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: 119 units Lot/code info: Product No. 781260 & 782112; UDI-DI: (01)00884838095076(21)5447, (01)00884838095076(21)5463, (01)00884838095076(21)5479, (01)00884838095076(21)5490, (01)00884838095076(21)5537, (01)00884838095076(21)5546, (01)00884838095076(21)8012, (01)00884838095076(21)8025, (01)00884838095076(21)8054, (01)00884838095076(21)8086, (01)00884838095076(21)8087, (01)00884838095076(21)8091, (01)00884838095076(21)8092, (01)00884838095076(21)8110, (01)00884838095076(21)8118, (01)00884838095076(21)8178, (01)00884838095076(21)8260, (01)00884838095076(21)8311, (01)00884838095076(21)8318, (01)00884838095076(21)8365, (01)00884838095076(21)8378, (01)00884838095076(21)8387, (01)00884838095076(21)8392, (01)00884838095076(21)8395, (01)00884838095076(21)8427, (01)00884838095076(21)8554, (01)00884838095076(21)8566, (01)00884838095076(21)8578, (01)00884838095076(21)8611, (01)00884838095076(21)8616, (01)00884838095076(21)8639, (01)00884838095076(21)8642, (01)00884838095076(21)8667, (01)00884838095076(21)8706, (01)00884838095076(21)8713, (01)00884838095076(21)8746, (01)00884838095076(21)8750, (01)00884838095076(21)8752, (01)00884838095076(21)8779, (01)00884838095076(21)8783, (01)00884838095076(21)8786, (01)00884838095076(21)8831, (01)00884838095076(21)8840, (01)00884838095076(21)8851, (01)00884838095076(21)8857, (01)00884838095076(21)8884, (01)00884838095076(21)8895, (01)00884838095076(21)8896, (01)00884838095076(21)8923, (01)00884838095076(21)8942, (01)00884838095076(21)8948, (01)00884838095076(21)9004, (01)008

UPC codes

00884838095076, 00884838098886

Source

Official record: FDA (Device enforcement) ↗

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