Recall Z-2520-2023 ยท JAK System, X-Ray, Tomography, Computed
Philips Healthcare
Incisive CT, software version 5.0
| Date | Sep 30, 2023 (initiated Aug 2, 2023) |
| Status | Open, Classified |
| Reason | Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: Coronary Computed Tomography Angiography (CTA) scan may not be triggered at the optimal time. Issue 2: Use of aborted surview for scan planning will result in deviation from intended scan area. Issue 3: Actual clinical scan with bariatric (Noah) couch will deviate from the intended scan area if surview scan length is greater than 1832mm. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Philips will inform customers of the issue via an Electronic Product Radiation Defect notification. Philips will schedule an appointment with customers to install the software update. |
| Quantity | 140 systems |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |