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Philips Healthcare (Suzhou) Co., Ltd.: Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.

Medical DevicesSource: FDA (device) · Date: 2026-09-02

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Philips Healthcare (Suzhou) Co., Ltd.
Product
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Reason / hazard
Potential of failing to trigger clinical scan during Bolus Tracking.
Classification
Class II
Status
Ongoing
Distribution / sold at
U.S. Nationwide and U.S. Territories distribution.
Recall initiated
2026-06-26
Code info
Device Identifier: (01)00884838085015, (01)00884838105508.
Product quantity
N/A
Voluntary mandated
FDA Mandated
City
Suzhou
State
N/A
Country
China
Event id
99511
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