Class II U.S. Food and Drug Administration

Philips Incisive CT with software V4.5&V5.0 recall: Potential of failing to trigger clinical scan during Bolus Tracking

Recall published last month

Potential of failing to trigger clinical scan during Bolus Tracking.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: Potential of failing to trigger clinical scan during Bolus Tracking.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2988-2026
Published
September 2, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Philips Healthcare Co., Ltd.
Product type
Medical devices
Units affected
N/A
Distribution
Nationwide
Made in
China
Lot / code info
Device Identifier: (01)00884838085015, (01)00884838105508.
UPC codes
00884838085015

Products covered by this recall

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

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00884838085015

Model or item number

On the rating label, the box or the instruction sheet.

  • 728143

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Philips Healthcare Co., Ltd. — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Philips Healthcare (Suzhou) Co., Ltd. — Suzhou Industrial Park, Suzhou

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Philips Healthcare Co., Ltd. medical devices recalled?

Potential of failing to trigger clinical scan during Bolus Tracking. Potential of failing to trigger clinical scan during Bolus Tracking.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00884838085015; model number 728143. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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