Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Incisive CT Recalled by Philips Healthcare Due to Philips has identified three software issues with compliance...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Philips Healthcare directly.
Affected Products
Incisive CT, software version 5.0
Quantity: 140 systems
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Philips Healthcare
Philips Healthcare has 21 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report