FDA-Device2026-01-14Class II

Philips Incisive CT

Philips Healthcare (Suzhou) Co., Ltd.
Hazard

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

Sold states
U.S. and U.S. territories
Affected count
35
Manufactured in
Suzhou Industrial Park, No. 258 Zhongyuan Road; Pingjiang, Suzhou, China
Products
Philips Incisive CT

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1003-2026

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