Agency classClass IIOur severity:High FDA (Devices)·Z-2602-2025·Announced 2025-10-01

Philips CT Systems Patient Support Table May Descend Unexpectedly

Philips is recalling certain CT systems because the patient support table may descend unexpectedly to the lowest position due to a component misalignment during replacement.

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 involving medical device equipment where unexpected patient support table descent presents a risk of patient injury or harm. Although no illnesses or injuries are explicitly reported in the source, the hazard (unexpected descent of a patient support structure during medical imaging) is significant and directly threatens patient safety.

Plain-English summary

Philips North America LLC is recalling Ingenuity Core128/Elite China CT systems, Model Number 728324. The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

Twenty-four units have been distributed worldwide, including throughout the United States and countries including Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Mauritius, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United Arab Emirates, and Vietnam.

If you own or operate one of these CT systems, contact Philips North America LLC for instructions on how to address this issue. The affected units can be identified by their Model Number 728324 and specific serial numbers listed in the recall documentation.

The recalled product

Product: Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324.
Manufacturer: Philips North America Llc
Category: Medical Device — Imaging Equipment / CT System
Hazard: fall-risk
unexpected-descent
component-misalignment
Affected units: 24

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

1. Model Number: 728324
UDI-DI: 00884838059863
Serial Numbers: 336821
337127
336823
336824
336828
336817
336952
336826
336847
336857
336876
336894
336948
336936
336947
337012
337074
337090

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 recalled by Philips North America Llc 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 10 products in this recall →

Same manufacturer · Philips North America Llc

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Same hazard · fall risk