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RecallWatchMedical Device Safety
Class IIOngoingZ-2600-2025

Philips North America LLC recalls Philips CT systems labeled as the following: 1. Ingenuity CT 728326

Philips North America LlcCambridge, MA, United StatesReported Oct 1, 2025 · 9 months ago
Legal News Analyst ·

Reason for recall

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

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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.

Lot / code information

Model
728321
UDI
00884838059498
Serial #
310033, 310095, 310098, 333020, 333135, 52084 — +69 moreShow all
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
728323
UDI
00884838059504
Serial #
30016, 320084, 320099, 336069, 336118, 336107 — +167 moreShow all
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
728326
UDI
00884838059511
Serial #
300017, 300163, 300209, 300251, 300019, 300045 — +31 moreShow all
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

What the firm is doing

Philips Medical notified consignees on about 08/11/2025 via letter. Consignees were instructed that they could continue using the affected systems accordance with the intended use and by following the recommendation: Observe the warning listed in Instructions for Use (IFU) and make sure that the patient is strapped securely to avoid dangling of the hands. Ensure that the patient is placed securely on the patient table and is not in danger of falling. Additionally, consignees were instructed to complete and return the provided response form, to circulate Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue and retain this letter with your system(s) until your system is inspected and corrected if necessary. Philips will contact consignees to schedule a time for a Philips Field Service Engineer (FSE) to visit each site and to inspect the affected system (FCO 72800832) and correct the system if necessary (FCO 72800833).

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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