Z-2595-2025Class II

Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance...

Name: Z-2595-2025 Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance...
Creator: Philips North America Llc
Published: 2025-08-13
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2025-08-13 / Open, Classified / root cause: manufacturing process

FDA source

Philips North America Llc began a recall of Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model Number: 728231. 3. Ingenuity... on 2025-08-13. FDA classified it as Class II and gives the reason as "The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2595-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-13
Posted: 2025-09-19
Recalling firm: Philips North America LLC
Product: Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model Number: 728231. 3. Ingenuity Flex, Model Number: 728317
Product code: JAK System, X-Ray, Tomography, Computed
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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).
Quantity in commerce: 181 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.
Product codes and lots: 1. Model Number: 728235; UDI-DI: N/A; Serial Numbers: 9223, 9115, 9225, 29144. 2. Model Number: 728231; UDI-DI: N/A; Serial Numbers: 95647, 9194, 95341, 95234, 10051, 95488, 10098, 95695, 10309, 95217, 95698, 10443, 10544, 10531, 10712, 10662, 95834, 9990, 9784, 95632, 9058, 9089, 9522, 9580, 9688, 9877, 9806, 9808, 9671, 9694, 9703, 9830, 29068, 9821, 9869, 9837, 90144, 95203, 95225, 95303, 95328, 95362, 95402, 95395, 9852, 95492, 95491, 9965, 9974, 95453, 95502, 10006, 10025, 95520, 10060, 95630, 95621, 10141, 95673, 10153, 10137, 95521, 90128, 9605, 10218, 10199, 10247, 10275, 10267, 10245, 10394, 10307, 90124, 10281, 95692, 29045, 95349, 95639, 10344, 10330, 10310, 10348, 10391, 10393, 10418, 10205, 9799, 10429, 29062, 10511, 10431, 10515, 10535, 10315, 10521, 10518, 10566, 10536, 10522, 10496, 10560, 10568, 90170, 10433, 10574, 10609, 10559, 10468, 95725, 10622, 95710, 95729, 10590, 10628, 10683, 10668, 10666, 10607, 95758, 10706, 95776, 95821, 95757, 95858, 95795, 9868, 10729, 95791, 10734, 10718, 95807, 10649, 95781, 95790, 95823, 95813, 10788, 10774, 95759, 95852, 95848, 95116, 95872, 95871, 95914, 95886, 95498, 95054, 95928, 95933, 95025, 90162, 95144, 29039, 95932, 95399, 10031, 90804, 10161, 10494, 9934, 90161. 3. Model Number: 728317; UDI-DI: N/A; Serial Numbers: 345040, 345053, 345155, 345031, 345048, 345056, 345055, 345063, 345050, 345100, 345117, 345122, 345133, 345131, 345171.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2595-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2595-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-19
Z-2596-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-19
Z-2597-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-19
Z-2598-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-19
Z-2599-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-19
Z-2600-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-19
Z-2601-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-19
Z-2602-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-19
Z-2603-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-19
Z-2604-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-19

Product code JAK

K033326Class IIPhilips Plus Computed Tomography SystemPhilips Medical Systems, Inc. / cleared 2003-10-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)