FDA (Devices) recall action 81403

Philips Medical Systems (Cleveland) Inc recalled 9 products on 2018-11-07

The FDA (Devices) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.

Products: 9
Announced: 2018-11-07
Critical: 0
Units: 9,166

Why these products were recalled

It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–9 of 9

HighFDA (Devices)··2018-11-07
Philips CT Scanner Software Recall for Misleading Calcium Score Reports
Philips is recalling 145 CT scanners because software version 4.2.0 generates confusing calcium score reports that may lead to patient mistreatment.
Product
Brilliance Big Bore Oncology CT (Model No. 728243) 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
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HighFDA (Devices)··2018-11-07
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.
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
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HighFDA (Devices)··2018-11-07
Philips CT Scanner Software Recall for Misleading Calcium Score Reports
Philips is recalling Ingenuity Core CT scanners with software version 4.1.6 because the Calcium Score report may display confusing plaque analyses, potentially leading to patient mistreatment.
Product
Ingenuity Core (Model No. 728321), 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 incl
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HighFDA (Devices)··2018-11-07
Philips IQon Spectral CT Software Recall for Misleading Calcium Score Reports
Philips is recalling IQon Spectral CT scanners with specific software versions because the Calcium Score report provides confusing and potentially misleading plaque analysis data.
Product
IQon Spectral CT (Model No. 728332), 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 devic
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HighFDA (Devices)··2018-11-07
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.
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
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HighFDA (Devices)··2018-11-07
Philips Ingenuity CT Software Recall for Misleading Calcium Score Reports
Philips is recalling Ingenuity CT scanners with software version 4.1.6 because the Calcium Score report may display confusing information, potentially leading to patient mistreatment.
Product
Ingenuity CT (Model No. 728326), 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 includ
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HighFDA (Devices)··2018-11-07
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.
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
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HighFDA (Devices)··2018-11-07
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.
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
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HighFDA (Devices)··2018-11-07
Philips Brilliance iCT Scanners Recalled for Misleading Calcium Score Reports
Philips is recalling Brilliance iCT scanners because software errors create confusing calcium score reports that may lead to patient mistreatment.
Product
Brilliance iCT (Model No. 728306), 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 incl
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