Agency classClass IIOur severity:High FDA (Devices)·Z-1825-2026·Announced 2026-04-22

Philips Spectral CT on Rails recalled over three software issues

Philips is recalling the Spectral CT on Rails after identifying three software issues affecting gantry movement, a confirmation prompt and head area planning. Three systems are affected.

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: FDA Class II recall for software faults affecting scanner movement and dose planning, a risk of harm with no injuries reported in the source.

Plain-English summary

Philips is recalling the Spectral CT on Rails, model number 728334, software version 5.1. The action covers three systems.

Philips has identified three software issues. First, during a continuous CT scan the gantry could remain at the current scan position after Go is pressed. Second, a prompt asking whether to select a previous surview should display but may not appear. Third, after performing a surview and planning a brain helical acquisition with the Brain Area DoseRight Index set to increase the dose, the Define Head Area option may behave incorrectly. The FDA classified the action as Class II.

Distribution was worldwide, covering Minnesota in the United States as well as France and the Netherlands. The systems are installed in hospital imaging departments rather than sold to consumers.

Facilities should identify affected systems using the model number and UDI codes in the recall notice and follow the instructions issued by Philips.

The recalled product

Product: Philips Spectral CT on Rails. Model Number: 728334.
Manufacturer: PHILIPS MEDICAL SYSTEMS
Category: Medical Device — CT scanner
Hazard: software-issue
gantry-movement
dose-planning
class-ii
imaging-system
Affected units: 3

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 (5)

Model Number: 728334. UDI: (01)00884838103627(21)1005
(01)00884838103627(21)1006
(01)00884838103627(21)1007. Software Version Number: 5.1.X. Serial Numbers: 1005
1006
1007.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · PHILIPS MEDICAL SYSTEMS

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