Agency classClass IIOur severity:High FDA (Devices)·Z-0304-2019·Announced 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.

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 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…
Manufacturer: Philips Medical Systems (Cleveland) Inc
Category: Medical Device — Computed Tomography (CT) Scanner
Hazard: misleading-information
patient-mistreatment
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.

See all 9 products in this recall →

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