Incisive CT, software version 5.0
FDA device recall Z-2520-2023 · posted 2023-09-30 · Open, Classified
Recall details
- Recalling firm
- Philips Healthcare
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Open, Classified
- Product code
- JAK
- Quantity affected
- 140 systems
- Distribution
- US Nationwide Distribution
- Date initiated
- 2023-08-02
- Date posted
- 2023-09-30
- Location
- Cambridge, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Philips Incisive CT (K212441) | Philips Healthcare (Suzhou) Co., Ltd. | 2022-04-27 |
| Philips Incisive CT on Trailer (K211168) | Philips Healthcare (Suzhou) Co., Ltd. | 2021-11-22 |
| Philips Incisive CT (K180015) | Philips Healthcare (Suzhou) Co., Ltd. | 2018-03-20 |