Agency classClass IIOur severity:High FDA (Devices)·Z-2260-2023·Announced 2023-08-09

Philips Incisive CT Scanner Mounting Box Poses Injury Risk

A metal mounting box in the Incisive CT Power scanner may detach and potentially injure operators or cause system failure. Philips is recalling 53 affected units distributed worldwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a medical device with a potential risk of user injury from a detached component. No injuries or hospitalizations have been reported, meeting the threshold for High severity as a risk-of-harm product without yet-reported injury.

Plain-English summary

The Incisive CT Power (Model 728148) is a computed tomography X-ray scanner used in medical imaging. A metal mounting box that forms part of the rotating scanner's heat exchanger may detach from its current position within the system.

If the metal mounting box detaches, two problems may occur: the loose part could make contact with other internal components and potentially cause injury to the operator or technician, or the system may shut down after emitting a loud noise when the part separates.

The recall affects 53 units that were distributed outside the United States, with installations in over 50 countries including China, Canada, Europe, Asia, and the Middle East.

Healthcare facilities and imaging centers with affected serial numbers should contact Philips North America for service instructions. The FDA recall number is Z-2260-2023.

The recalled product

Product: Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148
Manufacturer: Philips North America
Category: Medical Device — Diagnostic Imaging
Hazard: component-detachment
injury-risk
equipment-failure
Affected units: 53

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Philips North America under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Philips North America

See all →

Moderate
Philips Recalls SmartPath MRI Software Due to Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
Moderate
Philips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
Moderate
Philips MR 5300 Recalled for Incorrect Diffusion Tensor Imaging Data
FDA (Devices) · 2026-10-07
Moderate
Philips Ingenia Ambition MRI Systems Recalled for Incorrect DTI Data Exports
FDA (Devices) · 2026-10-07
Moderate
Philips MR 7700 Software Upgrade Recalled for Incorrect DTI Data
FDA (Devices) · 2026-10-07

Same hazard · component detachment