The Recall Desk
HighFDA (Devices)·Z-1324-2025·Announced 2025-03-19

Philips Spectral CT on Rails software recall due to scanning and movement issues

Philips is recalling one unit of Spectral CT on Rails software version 5.1.0 due to multiple software problems causing scanning issues, image errors, and unintended device movement.

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 a Class II FDA recall of a medical imaging device with software issues that create risk of harm through unintended movement and imaging errors. No hospitalization or injury reports are documented in the source material, placing this in the risk-of-harm category where injury has not yet been reported.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling one unit of Spectral CT on Rails (software version 5.1.0, model 728334). The device is distributed in Minnesota.

The recall is due to multiple software problems identified in version 5.1.0. These problems lead to various scanning issues, image errors, and unintended device movement. The software malfunctions can affect the device's proper operation and diagnostic image quality.

The recalled product

Product
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Manufacturer
Philips Medical Systems Nederland B.V.
Category
Medical Device — Imaging Equipment
Hazard
  • unintended-movement
  • imaging-error
  • software-malfunction

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 (4)

  • Software Version Number 5.1.0
  • Model number: 728334
  • UDI-DI: (01)00884838103627(21)1005
  • Serial Number (SN): 1005

Distribution

Distributed in 1 state:

  • MN

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