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Z-2988-2026Class 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
2026-09-02
Distribution
U.S. Nationwide and U.S. Territories distribution.
Firm state
N/A
Product quantity
N/A
Initiated by
FDA Mandated
Reason for recall
Potential of failing to trigger clinical scan during Bolus Tracking.
Product description
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Code / lot info
Device Identifier: (01)00884838085015, (01)00884838105508.
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 →