Reported Sep 2, 2026 · Ongoing · Updated Sep 16, 2026

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

Philips Healthcare (Suzhou) Co., Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips Healthcare (Suzhou) Co., Ltd. · Suzhou Industrial Park, No. 258 Zhongyuan Road; Pingjiang · Suzhou

Is this the product you have?

    • Philips Incisive CT with software V4.5&V5.0
    • Product Code 728143 and Product Code 728144
Lot codes and dates
  • Device Identifier
    • (01)00884838085015
    • (01)00884838105508

Where it was sold

  • Nationwide

Why it was recalled

Potential of failing to trigger clinical scan during Bolus Tracking.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (Enforcement Report)

Read the FDA (weekly enforcement report) notice

Data as of Sep 19, 7:12 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.