Agency classClass IIOur severity:High FDA (Devices)·Z-0078-2027·Announced 2026-10-14

Philips Spectral CT Systems Recalled for Software Issues Affecting Safety

Philips Medical Systems is recalling 539 Spectral CT systems due to software issues that may cause image artifacts, wrong slice thickness, or unintended system motion.

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: The recall is classified as FDA Class II, and the source describes software issues that may result in image artifacts, wrong slice thickness, or unintended system motion. The source does not report any illnesses, injuries, or deaths.

Plain-English summary

Philips Medical Systems is recalling 539 units of the Spectral CT and Spectral CT 7500 RT systems. The recall involves specific software versions and model numbers distributed in the United States and internationally.

The recall is being issued because software issues may affect the safety and performance of the systems. These issues may result in image artifacts, wrong slice thickness, or unintended system motion. The source text does not report any illnesses, injuries, or deaths associated with these issues.

Affected units were distributed in 21 U.S. states and numerous countries worldwide. Healthcare facilities should contact Philips Medical Systems for instructions on how to address the software issues.

The recalled product

Product: Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside U.S.); Model Numbers: 1. 728333 (U.S. and Outside U.S.), 2. 728340 (Outside U.S.), 3. 728344 (Outside U.S.), 4. 728345 (Outside U.S.);
Manufacturer: PHILIPS MEDICAL SYSTEMS
Category: Medical Device — Imaging Equipment
Hazard: software-defect
image-artifacts
unintended-motion
Affected units: 539

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: 728333 (U.S.)
UDI-DI: 1. 00884838101111
2. 00884838127876
Serial Numbers: 12055
12054
12052
398006
12044
12045
10237
10056
10194
12059
10278
10319
10143
10081
12047
12048
10198

Distribution

Distributed nationwide across the United States.

The notice also names 20 states specifically:

Same manufacturer · PHILIPS MEDICAL SYSTEMS

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