Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Potential of failing to trigger clinical scan during Bolus Tracking.
Class IIReported ongoing
Distribution: U.S. Nationwide and U.S. Territories distribution.
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3 reported ongoing
3 records in this archive. Latest source date Jun 26, 2026.
FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
Potential of failing to trigger clinical scan during Bolus Tracking.
Class IIReported ongoing
Distribution: U.S. Nationwide and U.S. Territories distribution.
Potential for incomplete scan due to unstable connection inside of floating sensor.
Class IIReported ongoing
Distribution: U.S. and U.S. territories
Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels, or the need for a CT rescan. These include: 1. Artifacts may occur on perfusion images, 2. Orientation label reversed in ...
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MD, ME, MI, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK,...
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This archive contains 3 records, including 3 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
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Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.