Philips Brilliance 64 CT System Software Error Recall
Philips is recalling seven Brilliance 64 CT systems because software may set the scan length differently than planned.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a Moderate severity score (2) in the absence of reported injuries or hospitalizations, as the defect involves software parameters rather than a direct physical hazard like fire or shock.
Plain-English summary
Philips Electronics North America Corporation is recalling seven units of the Philips Healthcare Brilliance 64 Computed Tomography X-ray system. The recall is due to a software defect that can cause the Axial (2 axis) scan length to be set to a different length than the user specified in the plan during specific protocol steps.
The affected systems were distributed nationwide in the United States and in numerous countries worldwide, including Argentina, Australia, Austria, and many others. The specific distribution list includes 60+ countries across the Americas, Europe, Asia, Africa, and the Middle East.
Healthcare facilities using these systems should contact Philips for instructions on how to resolve the software issue. The recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Philips Healthcare Brilliance 64 Computed Tomography X-ray system
- Manufacturer
- Philips Electronics North America Corporation
- Affected units
- 7
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 (1)
- 728231
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Philips Electronics North America Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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