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Recall Observatory FDA recall evidence

Device product

Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326, Model Number: 728323. 3. Ingenuity CT, Model Number: 728326.

Z-2600-2025

August 13, 2025

Class II

Product summary

Firm
Philips North America Llc
Event
Event 97468
Status
Ongoing
Classification
Class II
Quantity
285 units
Official record key
device-enforcement:Z-2600-2025

Official wording

Reason: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

Code information: 1. Model Number: 728321; UDI-DI: 00884838059498; Serial Numbers: 310033, 310095, 310098, 333020, 333135, 52084, 310005, 310019, 310030, 310038, 310050, 310057, 310053, 310075, 310126, 310009, 310101, 310108, 310157, 310170, 333024, 310171, 333061, 333021, 52007, 52017, 52039, 333053, 31001, 333130, 52025, 52037, 52056, 333132, 52063, 333077, 310288, 310230, 310221, 310238, 310294, 310286, 310233, 310259, 310283, 310293, 310262, 310274, 333092, 333107, 310317, 333131, 333118, 333124, 333151, 310326, 310323, 310340, 333153, 310356, 310382, 310378, 333166, 333179, 310397, 52103, 333193, 52121, 52122, 52157, 52161, 52153, 68106, 52194, 40009. 2. Model Number: 728323; UDI-DI: 00884838059504; Serial Numbers: 30016, 320084, 320099, 336069, 336118, 336107, 320271, 336237, 336769, 320439, 32291, 336447, 32358, 68164, 40085, 40075, 320008, 320037, 320019, 320017, 320071, 320042, 320055, 320101, 320108, 320104, 320117, 336056, 320122, 32058, 320129, 333019, 336030, 32016, 336028, 320070, 32003, 32004, 32014, 336070, 32010, 336033, 32089, 32072, 32048, 336067, 32076, 32061, 32046, 320233, 336076, 32094, 32001, 32065, 32130, 320322, 336708, 32084, 32105, 32103, 32096, 336704, 336130, 32118, 336108, 32143, 336115, 336129, 32135, 336109, 336113, 32136, 32137, 320251, 336735, 32028, 336114, 336158, 320258, 32163, 336175, 32149, 320284, 320270, 336784, 336767, 336762, 336770, 336177, 336754, 336768, 336774, 336781, 336246, 336758, 320278, 320356, 320363, 336772, 336259, 320281, 32169, 336785, 336797, 336783, 336796, 320313, 320304, 320300, 320315, 320311, 320327, 320314, 320346, 320365, 336801, 320320, 336266, 320368, 336286, 320353, 30035, 320352, 320376, 320379, 320382, 320397, 320375, 320409, 320422, 320420, 320417, 320424, 32180, 32177, 320432, 320494, 32207, 32185, 320450, 32188, 336354, 336355, 32205, 32211, 32216, 32231, 336396, 336387, 336403, 336423, 32283, 336391, 336433, 336437, 32323, 32346, 32330, 32339, 32338, 68116, 68131, 337000, 336492, 68159, 68155, 338034, 40030, 341006, 40038, 40044, 40063, 68187. 3. Model Number: 728326; UDI-DI: 00884838059511; Serial Numbers: 300017, 300163, 300209, 300251, 300019, 300045, 300039, 300090, 300089, 300096, 300097, 300133, 300114, 300203, 300148, 320103, 300160, 30013, 30006, 30007, 30026, 30034, 30029, 30045, 30031, 30043, 30044, 300239, 30046, 32045, 300228, 300236, 300231, 300230, 300238, 300249, 300259.

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Mauritius, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, Utd.Arab.Emir., Vietnam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.