Agency classClass IIOur severity:High FDA (Devices)·Z-0583-2025·Announced 2024-12-11

Spectral CT Devices Pose Collision and Misdiagnosis Software Risks

Philips Spectral CT and Spectral CT Plus devices may fail to update plan positioning during interventional procedures, creating collision risks to operators and patients. A software defect may also assign incorrect patient IDs, potentially causing misdiagnosis.

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 Class II FDA recall involves two serious software defects: plan box update failure during interventional procedures creates collision and injury risk to operator and patient; patient identification error could lead to misdiagnosis. However, the source reports no actual injuries or illnesses, and hazards are characterized as potential rather than confirmed, meeting the criterion for High severity: risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips North America LLC is recalling 301 units of Spectral CT and Spectral CT Plus devices (Model Numbers 728333, 728340, and 728344, software version 5.0.X). These computed tomography imaging systems are deployed in medical facilities worldwide.

The U.S. Food and Drug Administration has classified this as a Class II recall due to two software defects. First, during interventional procedures, the plan box may fail to update correctly, potentially causing collision with the operator or with a needle placed inside the patient. Second, a patient identification software issue may cause incorrect patient records to be associated with imaging data, which could lead to misdiagnosis.

The affected devices have been distributed throughout the United States and internationally to Australia, Austria, Belgium, China, Czech Republic, Denmark, Ecuador, France, Germany, Hong Kong, Israel, Italy, Japan, Jordan, Macao, Malaysia, Netherlands, New Zealand, Norway, Palestine, Panama, Poland, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, the United Kingdom, and Vietnam. Hospitals and imaging centers operating these devices should contact Philips North America LLC for information about remediation options.

The recalled product

Product: Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Manufacturer: Philips North America Llc
Category: Medical Device — CT Scanner
Hazard: collision-risk
misdiagnosis-risk
Affected units: 301

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)

10261
10264
10219
10265
10197
10182
10175
10192
10179
10196
10180
10188
10190
10181
10183
10178
10186
10185
10199
10184

Distribution

Distributed nationwide across the United States.

The notice also names 19 states specifically:

Same manufacturer · Philips North America Llc

See all →

High
Philips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
Moderate
Philips Achieva 1.5T MRI Systems Recalled for Software Memory Issue
FDA (Devices) · 2026-09-30
Moderate
Philips MR 7700 MRI Systems Recalled for Software Issue
FDA (Devices) · 2026-09-30
Moderate
Philips Ingenia MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
Moderate
Philips MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30

Same hazard · collision risk