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Philips brilliance ct big bore system

Official notice

1 Nov 2023

Last checked

1 Nov 2023

Medium riskHealth Canada

An official Health Canada notice concerns Philips brilliance ct big bore system. Philips has become aware of a potential safety issue with the Philips Big Bore RT and upgrade Brilliance CT Big Bore where it may be difficult for the user to accurately identify the image position under specific clinical scenarios. After performing an off-center reconstruction and sending the image data to other Therapy Planning Solution (TPS) workstations or exporting to a post processing software, a two-dimensional image shift (x and y coordinates) may occur. In oncology scenarios this could cause the contours to be misplaced or the iso center of the tumor to be incorrect. In radiology scenarios this could cause the relate function to show different positions on the intellispace portal or other post-processing workstations, when comparing images. Recall start date: October 13, 2023 Published 2023-11-01.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74510

Official notice

2023-11-01

The hazard

Philips has become aware of a potential safety issue with the Philips Big Bore RT and upgrade Brilliance CT Big Bore where it may be difficult for the user to accurately identify the image position under specific clinical scenarios. After performing an off-center reconstruction and sending the image data to other Therapy Planning Solution (TPS) workstations or exporting to a post processing software, a two-dimensional image shift (x and y coordinates) may occur. In oncology scenarios this could cause the contours to be misplaced or the iso center of the tumor to be incorrect. In radiology scenarios this could cause the relate function to show different positions on the intellispace portal or other post-processing workstations, when comparing images. Recall start date: October 13, 2023

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

74510

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Affected products

Product 1

Affected products - Philips CT Big Bore, Lot or serial number - All lots., Model or catalog number - 728242

Product 2

Affected products - Brilliance CT Big Bore System-Main Unit, Lot or serial number - All lots., Model or catalog number - 728244

Risk / hazard

Philips has become aware of a potential safety issue with the Philips Big Bore RT and upgrade Brilliance CT Big Bore where it may be difficult for the user to accurately identify the image position under specific clinical scenarios. After performing an off-center reconstruction and sending the image data to other Therapy Planning Solution (TPS) workstations or exporting to a post processing software, a two-dimensional image shift (x and y coordinates) may occur. In oncology scenarios this could cause the contours to be misplaced or the iso center of the tumor to be incorrect. In radiology scenarios this could cause the relate function to show different positions on the intellispace portal or other post-processing workstations, when comparing images. Recall start date: October 13, 2023

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Manufacturer

Not provided

Phone

Not provided

Brand: Philips.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

74510

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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