Philips CT systems labeled as the following recall
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.
Why was Philips CT systems labeled as the following recalled?
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
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?
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.
- 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.
- Recalling firm
- Philips North America Llc
- Quantity
- 285 units
- Distribution
- 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.
- Recall date
- October 1, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)