United StatesIncisive CT and CT 5300 computed tomography systems running software versions 4.5, 5.0, or 5.1 (Model 728143, UDI‑DI 00884838085015; listed serial numbers) are affected. They were recalled because screws of the tube heat exchanger on the rotating scanner may not be tightened after replacement, allowing the component to detach and contact other components during rotation, which could damage those components.
What's being recalled
Incisive CT; Software Version Number: 4.5, 5.0, 5.1;
CT 5300; Software Version Number: 4.5, 5.0, 5.1;
Recalling firm: Philips North America Llc, Cambridge, MA, United States.
How to identify it
1) Model Number: 728143; UDI-DI: 00884838085015; Serial Numbers: 500092, 500202, 500309, 500376, 500574, 500265, 500264, 510051, 500034, 500544, 500543, 500548, 500046, 500168, 500064, 500110, 500111, 500102, 500145, 500178, 500255, 500217, 500211, 500216, 500225, 33009, 500242, 500252, 500222, 500282, 33005, 500301, 33001, 33035, 33039, 33002, 33003, 33007, 33013, 33047, 33011, 33008, 33015, 33020, 33010, 33046, 33017, 33019, 33049, 33016, 33024, 33006, 33025, 33034, 33041, 33038, 33031, 33042, 33033, 33037, 33045, 33012, 500032, 500073, 500138, 500308, 33023, 500443, 500410, 500412, 500557, 500038, 500069, 500332, 500397, 510056, 500091, 500135, 510028, 510029, 500591, 500123, 500087, 500136, 500103, 500116, 500105, 500056, 500125, 500041, 500089, 500200, 500152, 500219, 500256, 500213, 500307, 510001, 500233, 500371, 500370, 500377, 510030, 510032, 510031, 500360, 510005, 510020, 500329, 500361, 500436, 500457, 500406, 500465, 500525, 500535, 510027, 500523, 33043, 500028, 500024, 500122, 500173, 510095, 500374, 500003, 500020, 500052, 500075, 500118, 500149, 500150, 500134, 500146, 500218, 500223, 500232, 500299, 500311, 500394, 500435, 500463, 33028, 500480, 500078, 500157, 500153, 500229, 500276, 500310, 500300, 500318, 500336, 500347, 500423, 500372, 500357, 500597, 500351, 500363, 500414, 500390, 500448, 500598, 500399, 500405, 500428, 500391, 500524, 500498, 500422, 500526, 500542, 500541, 500565, 500575, 500578, 500592, 500585, 500593, 500586, 500604, 500581, 500577, 500393, 500210, 500296, 510050, 510026, 500049, 500067, 500076, 500081, 500249, 500368, 500415, 500426, 500522, 500550, 500554, 500569, 500567, 500494, 500187, 500129, 500161, 500175, 500156, 500186, 500141, 500142, 500143, 500144, 500160, 500155, 500185, 500204, 500181, 500182, 500191, 500190, 500201, 500228, 500220, 500221, 500272, 500235, 500237, 500262, 500267, 500268, 500250, 500278, 500275, 500284, 500285, 500287, 500288, 500286, 500293, 510009, 510002, 500334, 510010, 510015, 510016…
The hazard
If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Bhutan, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Ethiopia, France, FrenchPolynesia, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Macedonia, Malaysia, Mauritius, Mexico, Moldova, Montenegro, Montserrat, Morocco, Mozambique, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Papua Nw Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Rwanda, Saint Kitts, Saint Lucia, Saudi Arabia, Serbia, Sint Maarten (D, Slovakia, South Africa, South Korea, Spain, St.Pier,Miquel., Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad,Tobago, Tunisia, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)