The Recall Desk
HighFDA (Devices)·Z-2595-2025·Announced 2025-10-01

Philips CT Systems Patient Support Table May Descend Unexpectedly

Philips CT systems' patient support tables may descend unexpectedly to the lowest position due to ball screw misalignment after component replacement. This poses a fall risk to patients.

What this means for you

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 for a mechanical failure in the patient support table that presents a risk of patient harm through unexpected descent. No injuries are reported in the available recall information. Per the rubric, risk-of-harm products without reported injuries are classified as High (score 3).

Plain-English summary

Philips North America LLC is recalling three models of Philips CT imaging systems. The patient support table (couch) may descend unexpectedly to the lowest position due to misalignment of a ball screw component after it is replaced.

The recalled models are the Brilliance CT 40 Channel (Model 728235), Brilliance CT 64 Channel (Model 728231), and Ingenuity Flex (Model 728317). A total of 181 units have been distributed worldwide to the United States and numerous countries internationally.

The unexpected descent of the patient support table poses a potential risk to patient safety during imaging procedures. This recall has been classified as FDA Class II.

The recalled product

Product
Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model Number: 728231. 3. Ingenuity Flex, Model Number: 728317
Manufacturer
Philips North America Llc
Hazard
  • mechanical-failure
  • patient-fall-risk

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: 728235
  • UDI-DI: N/A
  • Serial Numbers: 9223
  • 9115
  • 9225
  • 29144. 2. Model Number: 728231
  • Serial Numbers: 95647
  • 9194
  • 95341
  • 95234
  • 10051
  • 95488
  • 10098
  • 95695
  • 10309
  • 95217
  • 95698
  • 10443
  • 10544
  • 10531

Distribution

Distributed nationwide across the United States.