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 (Suzhou) Co., Ltd. Due to Multiple software issues which have the potential to...
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 (Suzhou) Co., Ltd. directly.
Affected Products
Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
Quantity: 828
Why Was This Recalled?
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 2D images, 3. Auto voice does not work during the cardiac scan, 4. Auto voice and operators voice are too quiet, patient cant hear, 5. Not all of the images are reconstructed in some cases, 6. No image displayed on the console monitor after enabling CCT Single Scan, 7. Ring artifact appears in 32x0.625 collimation of bone scan when soft tissue view is selected, 8. A design defect where the error couch motion signal of couch firmware causes couch to identify current position as target position in next protocol, and 9. calcium scoring study split into separate series after loading to ISP.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Philips Healthcare (Suzhou) Co., Ltd.
Philips Healthcare (Suzhou) Co., Ltd. has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report