FDA-Device2026-09-02Class IIPROCESSING DEFECT
Philips Incisive CT scanner recalled for Bolus Tracking scan failure risk
What this means
Philips Incisive CT scanners running software versions V4.5 or V5.0 may fail to start a clinical scan during Bolus Tracking imaging procedures. This could delay or prevent necessary diagnostic scans from being acquired.
- Contact Philips Healthcare for software updates or device inspection if you operate an affected Incisive CT system
- Verify your system's software version and product code (728143 or 728144) against the recall notice
The agency's original wording
Hazard
Potential of failing to trigger clinical scan during Bolus Tracking.
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S. Nationwide and U.S. Territories distribution.
Affected count
N/A
Manufactured in
Suzhou Industrial Park, No. 258 Zhongyuan Road; Pingjiang, Suzhou, N/A, China
Products
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2988-2026Want us to check the next one for you?
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