Philips Healthcare (suzhou) Co., Ltd.: System, X-ray, Tomography, Computed
Recall Summary Philips Healthcare is recalling certain Incisive CT scanning systems (software versions V4.5 and V5.0) distributed nationwide because they may fail to start a clinical scan when using Bolus Tracking, a technique that times imaging based on contrast material flow. This Class II recall affects CT systems in all U.S. states and territories.
- Recalling firm
- Philips Healthcare (Suzhou) Co., Ltd.
- Product
- Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
- Reason
- Potential of failing to trigger clinical scan during Bolus Tracking.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-26
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- U.S. Nationwide and U.S. Territories distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/984efc48-c848-49a6-88f1-53f78cfba329