Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT Chin
FDA device recall Z-2652-2026 · posted 2026-07-27 · Open, Classified
Recall details
- Recalling firm
- PHILIPS MEDICAL SYSTEMS
- Reason for recall
- The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.
- Action taken
- An Electronic Product Radiation Correction letter was issued to its customers describing the product, problem and actions to be taken by its customers. To identify the software version of your product: 1. Click the Help button. 2. Select About and the software version is then displayed. The software version begins with v. 3.You may continue to use your system(s) in accordance with the intended use. 4. Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Electronic Product Radiation Correction Letter, understanding of the issues, and required actions to be taken. 5. Circulate this Electronic Product Radiation Correction Letter to all users of this device so that they are aware of the issues. Please retain this letter with your system(s) until a solution is installed on your system; ensure the letter is in a place likely to be seen/viewed. Actions planned by Philips to correct the problem Philips will contact you to schedule a time for a Philips Field Service Engineer (FSE) to visit your site and install the software update to resolve the issues. If you need any further information or support concerning this issue, please contact your local Philips representative: For North America, contact the Customer Care Solutions Center (1-800-722-9377).
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Open, Classified
- Product code
- JAK
- Quantity affected
- 182
- Distribution
- US Nationwide Distribution including Puerto Rico
- Date initiated
- 2026-06-11
- Date posted
- 2026-07-27
- Location
- Cambridge, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Philips Ingenuity CT (K160743) | Philips Medical Systems (Cleveland), Inc. | 2016-08-08 |