Philips Brilliance iCT SP CT Scanners Recalled for Misleading Calcium Score Reports
Philips is recalling 626 Brilliance iCT SP CT scanners because specific software versions generate confusing calcium score reports that may lead to patient mistreatment.
What this means for you
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 involves a high-risk medical device where a software defect may lead to patient mistreatment, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 626 Brilliance iCT SP Computed Tomography (CT) scanners, Model No. 728311, running software versions 4.7.0 or 4.7.2. The devices were distributed nationwide in the United States.
The recall was issued because the scanners provide confusing information in the "Impressions" section of the Calcium Score report. The generated reports present multiple analyses of the amount of plaque detected as if they all apply to the patient simultaneously. This misleading guidance may confuse users and potentially lead to the mistreatment of patients.
Healthcare facilities should contact Philips Medical Systems (Cleveland) Inc for instructions on how to resolve the issue. Consumers should not use these specific software versions for calcium score reporting until the issue is addressed.
The recalled product
- Product
- Brilliance iCT SP (Model No. 728311, Software Version 4.7.0 or 4.7.2 Product Usage: 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
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 626
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)
- Software Version 4.7.0 or 4.7.2
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 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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