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Philips Healthcare (Suzhou) Co., Ltd.: Philips Incisive CT

Medical DevicesSource: FDA (device) · Date: 2026-01-14

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
Reason / hazard
Potential for incomplete scan due to unstable connection inside of floating sensor.
Classification
Class II
Status
Ongoing
Distribution / sold at
U.S. and U.S. territories
Recall initiated
2025-12-03
Product quantity
35
Voluntary mandated
FDA Mandated
City
Suzhou
Country
China
Event id
98238
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