Philips CT Scanner Software Recall for Misleading Calcium Score Reports
Philips is recalling Ingenuity Core 128 CT scanners with software version 4.1.6 because the Calcium Score report may display confusing information, potentially leading to patient mistreatment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 potential patient mistreatment due to misleading data, 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 Ingenuity Core 128 Computed Tomography (CT) scanners (Model No. 728323) equipped with software version 4.1.6. These devices are intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data.
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 be confusing to the user and could lead to the mistreatment of the patient.
The affected units were distributed nationwide in the United States. Users of these devices should contact Philips Medical Systems for further instructions regarding the software issue.
The recalled product
- Product
- Ingenuity Core 128 (Model No. 728323), 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…
- 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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