Recall Z-2988-2026 ยท JAK System, X-Ray, Tomography, Computed
Philips Healthcare (Suzhou) Co., Ltd.
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
| Date | Aug 21, 2026 (initiated Jun 26, 2026) |
| Status | Open, Classified |
| Reason | Potential of failing to trigger clinical scan during Bolus Tracking. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Philips notification dated June 26, 2026 will inform customers of the issue via an Electronic Product Radiation Correction notification. Philips will schedule an appointment with customers to update the software free of charge. Customers who need additional information or support concerning this issue should be directed to their local Philips representative at 1-800-722-9377 (Philips Customer Care Solutions Center). Philips reference: 2026-PD-CTAMI-108. |
| Distribution | U.S. Nationwide and U.S. Territories distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212441 | Philips Incisive CT Philips Healthcare (Suzhou) Co., Ltd., Apr 27, 2022 |