Philips Brilliance 64 CT Scanner Software Recall for Misleading Reports
Philips is recalling Brilliance 64 CT scanners with software version 4.1.6 because the Calcium Score report may display confusing information, 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 hazard is misleading information that may lead to patient mistreatment, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 1,890 units of the Brilliance 64 (Model No. 728231) Computed Tomography X-ray systems. The recall affects units running software version 4.1.6 that were distributed nationwide in the United States.
The recall was initiated because scanners running this specific software version provide confusing information in the "Impressions" section of the Calcium Score report. The generated report displays 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 and users of these devices should contact Philips Medical Systems for instructions on how to resolve the software issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Brilliance 64 (Model No. 728231), Software version 4.1.6 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 may inclu
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 1,890
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 4.1.6
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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