Device product
Incisive CT, software version 5.0
Z-2520-2023
Product summary
- Event
- Event 93000
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 140 systems
- Official record key
device-enforcement:Z-2520-2023
Official wording
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.
Code information: software version 5.0
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Device software or design
software issues with compliance concerns to Subchapter J: Issue