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Recall Observatory FDA recall evidence

Device product

Philips Incisive CT

Z-1003-2026

December 03, 2025

Class II

Product summary

Firm
Philips Healthcare (Suzhou) Co., Ltd.
Event
Event 98238
Status
Ongoing
Classification
Class II
Quantity
35
Official record key
device-enforcement:Z-1003-2026

Official wording

Reason: Potential for incomplete scan due to unstable connection inside of floating sensor.

Code information: Unavailable

Distribution pattern: U.S. and U.S. territories

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for incomplete scan due to unstable connection inside of floating sensor.