Z-0395-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 29, 2023
- Initiation Date
- October 23, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 119 units
Product Description
SmartPath to dStream for 1.5T
Reason for Recall
Potential component failure in the Gradient Coil could product smoke and/or fire.
Distribution Pattern
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, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Romania, Russian Fed., Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, UAE, Venezuela, Vietnam, & Yemen.
Code Information
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)00884838095076(21)9013, (01)00884838095076(21)10029, (01)00884838095076(21)10044, (01)00884838095076(21)10075, (01)00884838095076(21)10079, (01)00884838095076(21)10130, (01)00884838095076(21)10151, (01)00884838095076(21)10164, (01)00884838095076(21)10170, (01)00884838095076(21)10174, (01)00884838095076(21)10185, (01)00884838095076(21)10191, (01)00884838095076(21)10458, (01)00884838095076(21)10511, (01)00884838095076(21)10513, (01)00884838095076(21)10554, (01)00884838095076(21)10906, (01)00884838095076(21)10915, (01)00884838095076(21)11031, (01)00884838095076(21)11047, (01)00884838095076(21)11062, (01)00884838095076(21)11076, (01)00884838095076(21)11085, (01)00884838095076(21)11091, (01)00884838095076(21)11102, (01)00884838095076(21)12030, (01)00884838095076(21)13011, (01)00884838095076(21)13029, (01)00884838095076(21)13032, (01)00884838095076(21)13062, (01)00884838095076(21)18038, (01)00884838095076(21)18670, (01)00884838095076(21)18761, (01)00884838095076(21)18957, (01)00884838095076(21)20071, (01)00884838095076(21)20111, (01)00884838095076(21)20226, (01)00884838095076(21)21062, (01)00884838095076(21)21213, (01)00884838095076(21)21576, (01)00884838095076(21)21582, (01)00884838095076(21)21801, (01)00884838095076(21)21814, (01)00884838095076(21)22013, (01)00884838095076(21)22017, (01)00884838095076(21)22031, (01)00884838095076(21)22086, (01)00884838095076(21)22098, (01)00884838095076(21)22102, (01)00884838095076(21)22144, (01)00884838095076(21)22157, (01)00884838095076(21)22248, (01)00884838095076(21)30033, (01)00884838095076(21)32218, (01)00884838095076(21)33044, (01)00884838095076(21)33246, (01)00884838095076(21)39003, (01)00884838095076(21)39024, (01)00884838095076(21)39031, (01)00884838095076(21)39037, (01)00884838095076(21)72054, (01)00884838095076(21)72243, (01)00884838095076(21)72250, (01)00884838098886(21)10128, (01)00884838098886(21)21893, (01)00884838098886(21)32580, (01)00884838098886(21)32798; Serial No. 5447, 5463, 5479, 5490, 5537, 5546, 8012, 8025, 8054, 8086, 8087, 8091, 8092, 8110, 8118, 8178, 8260, 8311, 8318, 8365, 8378, 8387, 8392, 8395, 8427, 8554, 8566, 8578, 8611, 8616, 8639, 8642, 8667, 8706, 8713, 8746, 8750, 8752, 8779, 8783, 8786, 8831, 8840, 8851, 8857, 8884, 8895, 8896, 8923, 8942, 8948, 9004, 9013, 10029, 10044, 10075, 10079, 10130, 10151, 10164, 10170, 10174, 10185, 10191, 10458, 10511, 10513, 10554, 10906, 10915, 11031, 11047, 11062, 11076, 11085, 11091, 11102, 12030, 13011, 13029, 13032, 13062, 18038, 18670, 18761, 18957, 20071, 20111, 20226, 21062, 21213, 21576, 21582, 21801, 21814, 22013, 22017, 22031, 22086, 22098, 22102, 22144, 22157, 22248, 30033, 32218, 33044, 33246, 39003, 39024, 39031, 39037, 72054, 72243, 72250, 10128, 21893, 32580, 32798.