Incisive CT; Software Version Number: 4.5, 5.0, 5.1;

What Should You Do?

1. Check if you have this product:
   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, 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530583, 530517, 530541, 530544, 530516, 530518, 530556, 530520, 530570, 530519, 530560, 530557, 530525, 530532, 530528, 530558, 530587, 530555, 530531, 530540, 530546, 530539, 530548, 530553, 530551, 530568, 530573, 530586, 530582, 530565, 530580, 530590, 530595, 510014, 500396, 500579, 530354, 500193, 500098, 500327, 500419, 500420, 500388, 500093, 500355, 500380, 510053, 500070, 500065, 500261, 500441, 510012, 500432, 500006, 500447, 500580, 500620, 500304, 500587, 500117, 500404, 500366, 500417, 500007, 500025, 500022, 500033, 500037, 500057, 500027, 500151, 500408, 500050, 500063, 500072, 500094, 500147, 500148, 500398, 500243, 500236, 500246, 500260, 500277, 500335, 510000, 500315, 500369, 500389, 500381, 500466, 500475, 500547, 510054, 500021, 500115, 500053, 500095, 500077, 500170, 500362, 500560, 500230, 500573, 500582; 2) Model Number: 728144; UDI-DI: 00884838105508; Serial numbers: 552070, 552094, 34415, 34010, 552036, 550138, 550133, 552051, 550320, 550076, 550319, 550190, 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2. Do not eat it: Even if it looks and smells fine, do not consume this product.
3. Throw it away or return it: You can return the product to the store for a full refund.
4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
5. Report problems: Report any issues to the FDA's Safety Reporting Portal.