SmartPath to dStream for 1.5T recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product

SmartPath to dStream for 1.5T

Recalling firm

Philips North America Llc

Quantity

119 units

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, 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.

Recall date

November 29, 2023

Classification

Class II

Status

Ongoing

Agency

FDA (device)