Philips CT Systems Recalled for Software Image Overlap Defect
Philips is recalling Brilliance 64 and Ingenuity CT systems because CIRS 4.0 Beta 2 software may cause images to overlap during reconstruction.
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. The hazard involves a software defect causing image overlap, which is a functional error rather than a direct physical injury risk, fitting the criteria for moderate severity.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling six units of the Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Systems. The recall involves a defect in the CIRS 4.0 Beta 2 software where images may be overlapped or superimposed on other images during the reconstruction process.
The issue was detected by a customer during a Field Test, which is a customer external evaluation period. Philips has disabled the affected feature at all sites currently evaluating the 4.0 Beta 2 software. The company plans to issue a software update to address the problem.
The affected devices were distributed worldwide, including in the United States (Ohio) and in Australia, China, Belgium, Israel, and Sweden. Users of these systems should contact Philips for information regarding the software update.
The recalled product
- Product
- The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 6
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 (8)
- 91003
- 30018
- 95504
- 300004
- 300030
- 300010
- 95130
- 95157
Distribution
Distributed in 1 state:
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