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CLASS II · ModerateFDA

Philips Healthcare (Suzhou) Co., Ltd. recalls Philips Incisive CT with software V4.5&V5.0

📅 Jun 26, 2026 · 📍 Nationwide
Recalling company
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 – may cause temporary or medically reversible health consequences
Recall date
Jun 26, 2026
Reported
Sep 2, 2026
Distribution
U.S. Nationwide and U.S. Territories distribution.
Status
Ongoing
Quantity
N/A
Lot / codes
Device Identifier: (01)00884838085015, (01)00884838105508.
Company location
Suzhou, N/A
Recall type
FDA Mandated
Recall number
Z-2988-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2988-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.