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Z-1003-2026Class II

Philips Healthcare (Suzhou) Co., Ltd.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Philips Healthcare (Suzhou) Co., Ltd.
Product type
Device
Status
Ongoing
Report date
2026-01-14
Distribution
U.S. and U.S. territories
Product quantity
35
Initiated by
FDA Mandated
Reason for recall

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

Product description

Philips Incisive CT

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →