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MEDICAL DEVICE RECALLMODERATE

Philips Incisive CT Software

Philips Incisive CT software V4.5/V5.0 recalled for Bolus Tracking scan trigger failure.

What to do

If you use a Philips Incisive CT system with software V4.5 or V5.0, contact Philips Healthcare immediately to arrange for a software update or corrective action. Do not attempt to modify the software yourself.

Recalled
Listed
Updated
Recall No.
Z-2988-2026
Agency
FDA
Firm
Philips Healthcare (Suzhou) Co., Ltd.
Recall ID
99511
Status
ONGOING

Why it was recalled

Philips Healthcare (Suzhou) Co., Ltd. is recalling the Incisive CT system with software versions V4.5 and V5.0 (Product Codes 728143 and 728144) due to a potential failure to trigger the clinical scan during Bolus Tracking, which could delay or prevent the intended imaging procedure.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

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

UDI-DI
00884838085015, 00884838105508

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Device Defect recalls

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Editorial summary by Recall Canary · summary updated 2026-08-23 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification