Philips Brilliance CT 64-Channel Systems Recalled for Software Defects
Philips is recalling four Brilliance CT 64-channel systems due to software errors affecting image quality, dose control, and heart rate measurements.
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 recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The issues are software-related functional errors (image artifacts, dose control, heart rate display) rather than immediate physical hazards like fire or shock, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls without reported harm.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling four units of the Brilliance CT 64-channel with Essence technology. These computed tomography X-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data. The recall involves specific serial numbers: 9654, 95130, 95157, and 95504.
The recall is due to five identified software issues: Fast Get Ready is incorrectly enabled during service procedures; contrast annotation is missing for some images when manual contrast was administered; dot artifacts appear intermittently after startup; heart rate measured values incorrectly remain constant for some heart rate change conditions; and DoseRight is incorrectly enabled when the Exam Card specified disabling it. Additionally, tube heat prediction issues were noted.
The affected units were distributed worldwide, including nationwide in the United States and in numerous international countries. No specific illnesses or injuries are reported in the source text. Consumers and healthcare facilities should contact the manufacturer for instructions on resolving these software defects.
The recalled product
- Product
- Computed Tomography X-ray Systems Brilliance CT 64-channel with Essence technology. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 4
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 (4)
- Brilliance CT 64-channel with Essence technology: Model #728231
- Serial #s: 9654
- 95130
- 95157 & 95504.
Distribution
Part of a larger recall action
This product is one of 6 recalled by Philips Medical Systems (Cleveland) Inc 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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