FDAClass IISeptember 2, 2026

Philips Incisive CT with software V4.5&V5.0 recall

Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.

Why was Philips Incisive CT with software V4.5&V5.0 recalled?

Potential of failing to trigger clinical scan during Bolus Tracking.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Device Identifier: (01)00884838085015, (01)00884838105508.

Product
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Recalling firm
Philips Healthcare (Suzhou) Co., Ltd.
Quantity
N/A
Distribution
U.S. Nationwide and U.S. Territories distribution.
Recall date
September 2, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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