Philips Brilliance iCT and iCT SP CT Systems Software Update Recall
Philips is issuing a software update for Brilliance iCT and iCT SP systems to address non-conformances that do not result in unacceptable hazards.
What this means for you
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 source explicitly states that none of the nonconformances result in unacceptable hazards, classifying this as a voluntary precautionary recall with low-risk issues.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is issuing a software update (version 3.2.4) for the Brilliance iCT and iCT SP Computed Tomography X-Ray Systems. This recall affects systems currently running software versions 3.2.0, 3.2.1, or 3.2.3. The update addresses a number of non-conformances identified during a review.
The recall covers 241 units distributed worldwide, including the United States and numerous international countries. The Brilliance iCT and iCT SP systems are used to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data. The devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories.
According to the source text, a review was conducted of all nonconformances fixed by the software upgrade, and none of these nonconformances result in unacceptable hazards. The nonconformance with the highest score was documented in the source, though specific details regarding the nature of the defect or specific injury risks are not provided in the excerpt.
The recalled product
- Product
- The Brilliance iCT and iCT SP 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 equipment,
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 241
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)
- Brilliance iCT: Model# 728306 Brilliance iCT SP: Model# 728311
Distribution
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