Philips CT Scanner Software Recall for Misleading Calcium Score Reports
Philips is recalling 145 CT scanners with software version 4.2.0 because the Calcium Score report may display confusing plaque analyses, potentially leading 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 risk-of-harm product where the software defect may lead to patient mistreatment, but the source text does not report any specific injuries or illnesses, fitting the High severity criteria.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 145 units of the Brilliance Big Bore Radiology CT (Model No. 728244) equipped with software version 4.2.0. The recall is due to a software defect that generates confusing information in the "Impressions" section of the Calcium Score report.
The affected software provides multiple analyses of the amount of plaque detected, presenting them as if they all apply to the patient simultaneously. This misleading guidance may confuse users and potentially lead to the mistreatment of patients.
The recalled devices were distributed nationwide in the United States. Healthcare facilities using these specific scanners should contact Philips Medical Systems for instructions on how to resolve the software issue.
The recalled product
- Product
- Brilliance Big Bore Radiology CT (Model No. 728244) software version 4.2.0 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
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 145
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 4.2.0
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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