PlainRecalls
FDA Devices Moderate Class II Terminated

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 may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

Reported: November 7, 2018 Initiated: June 7, 2017 #Z-0311-2019

Product Description

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 may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

Reason for Recall

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.

Details

Units Affected
626
Distribution
US Nationwide Distribution
Location
Cleveland, OH

Frequently Asked Questions

What product was recalled? ▼
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 may include signal analysts and display equipment, patient and equipment supports, components, and accessories.. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 626.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 7, 2018. Severity: Moderate. Recall number: Z-0311-2019.

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