Recall Z-2603-2025
Philips North America Llc · initiated August 13, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325.
Codes / lots: 1. Model Number: 728325; UDI-DI: N/A; Serial Numbers: 338014, 338028, 338019.
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.
FDA-determined cause: Process control
Action taken
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).
Details
- Recall number
- Z-2603-2025
- Initiated
- August 13, 2025
- Posted by FDA
- September 19, 2025
- Product code
- JAK – System, X-Ray, Tomography, Computed
- Quantity
- 3 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…
- Recalling firm
- Philips North America Llc, Cambridge, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2595-2025 Class II | Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number:…The patient support table (couch) may descend unexpectedly to the lowermost position due to a component… | 08/13/2025Open, Classified |
| Z-2596-2025 Class II | Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number:…The patient support table (couch) may descend unexpectedly to the lowermost position due to a component… | 08/13/2025Open, Classified |
| Z-2597-2025 Class II | Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2.…The patient support table (couch) may descend unexpectedly to the lowermost position due to a component… | 08/13/2025Open, Classified |
| Z-2598-2025 Class II | Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.The patient support table (couch) may descend unexpectedly to the lowermost position due to a component… | 08/13/2025Open, Classified |
| Z-2599-2025 Class II | Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311.The patient support table (couch) may descend unexpectedly to the lowermost position due to a component… | 08/13/2025Open, Classified |
| Z-2600-2025 Class II | Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number:…The patient support table (couch) may descend unexpectedly to the lowermost position due to a component… | 08/13/2025Open, Classified |
| Z-2601-2025 Class II | Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.The patient support table (couch) may descend unexpectedly to the lowermost position due to a component… | 08/13/2025Open, Classified |
| Z-2602-2025 Class II | Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model…The patient support table (couch) may descend unexpectedly to the lowermost position due to a component… | 08/13/2025Open, Classified |
| Z-2604-2025 Class II | Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.The patient support table (couch) may descend unexpectedly to the lowermost position due to a component… | 08/13/2025Open, Classified |