Food, drugs, devices › Philips North America Llc
Device recall: Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Chan
FDA enforcement event 97468 is a device recall by Philips North America Llc of Cambridge, MA, initiated 13 Aug 2025 and classified Class II, with 10 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Philips North America Llc has 129 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Philips North America Llc, Cambridge, MA.
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."
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2595-2025 | 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 | 181 units | Class II | Ongoing | 1 Oct 2025 |
| Z-2596-2025 | Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number: 728246. 3. Brilliance CT 6 Slice, Model Number: 728256. | 73 units | Class II | Ongoing | 1 Oct 2025 |
| Z-2597-2025 | Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model Number: 728244. | 33 units | Class II | Ongoing | 1 Oct 2025 |
| Z-2598-2025 | Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306. | 210 units | Class II | Ongoing | 1 Oct 2025 |
| Z-2599-2025 | Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311. | 14 units | Class II | Ongoing | 1 Oct 2025 |
| Z-2600-2025 | 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. | 285 units | Class II | Ongoing | 1 Oct 2025 |
| Z-2601-2025 | Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332. | 81 units | Class II | Ongoing | 1 Oct 2025 |
| Z-2602-2025 | Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324. | 24 units | Class II | Ongoing | 1 Oct 2025 |
| Z-2603-2025 | Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325. | 3 units | Class II | Ongoing | 1 Oct 2025 |
| Z-2604-2025 | Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307. | 6 units | Class II | Ongoing | 1 Oct 2025 |
Context
Other enforcement events for Philips North America Llc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 7 Aug 2026 | Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: | Device | Class II | 4 |
| 1 Jul 2026 | Cardiac Workstation 5000. Product Number: 860439. | Device | Class II | 2 |
| 5 Jun 2026 | Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5 | Device | Class II | 1 |
| 26 May 2026 | Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A | Device | Class II | 2 |
| 1 May 2026 | DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035. | Device | Class II | 1 |
| 7 Jan 2026 | Brilliance iCT; Product Code (REF): 728306; | Device | Class II | 4 |
| 12 Dec 2025 | Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor. | Device | Class II | 1 |
| 31 Oct 2025 | IntelliVue MP2. Product Number: M8102A. | Device | Class II | 22 |
| 29 Oct 2025 | Incisive CT; Software Version Number: 4.5, 5.0, 5.1; | Device | Class II | 2 |
| 29 May 2025 | Spectral CT. Computed tomography X-ray system. | Device | Class II | 1 |
All 129 events for Philips North America Llc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.