Incisive CT, software version 5.0
This recall is currently active, issued September 30, 2023. It was issued by Philips Healthcare.
- Company
- Philips Healthcare
- Recall Initiated
- August 2, 2023
- Posted
- September 30, 2023
- Recall Number
- Z-2520-2023
- Quantity
- 140 systems
- Firm Location
- Cambridge, MA
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide Distribution
Lot / Code Info
software version 5.0
Root Cause
Radiation Control for Health and Safety Act
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.