Agency classClass IIOur severity:High FDA (Devices)·Z-0303-2019·Announced 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.

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 145 units of the Brilliance Big Bore Oncology CT (Model No. 728243) running software version 4.2.0. The devices were distributed nationwide in the United States.

The recall was initiated because the software provides 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 lead to the mistreatment of the patient.

Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the software issue. The FDA classifies this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

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…
Manufacturer: Philips Medical Systems (Cleveland) Inc
Category: Medical Device — Computed Tomography (CT)
Hazard: mis-labeling
incorrect-data
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.

See all 9 products in this recall →

Same manufacturer · Philips Medical Systems (Cleveland) Inc

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Same hazard · mis labeling