Brilliance 40-64 Slice CT System, Brilliance ICT System - System, Brilliance ICT SP System - Main, Ingenuity CT System (2019-06-25)

Starting date:

June 25, 2019

Posting date:

July 19, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-70453

Last updated: 2019-07-19

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  Reason
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  Affected products

Affected Products

A. Brilliance 40-64 Slice CT System

B. Brilliance ICT System- System

C. Brilliance ICT SP System - Main

D. Ingenuity CT System

Reason

There are 3 scenarios users may experience which result in identical images that are incorrectly labeled as phase tolerance images:

1. When performing a Step and Shoot acquisition with phase tolerance selected, images may be reconstructed identically (a single phase), but are labeled as different phases. This occurs when ""Start Final Recon"" is selected prior to display of the ECG wave at the top of the acquisition window.
2. When performing a Step and Shoot acquisition with phase tolerance selected, images may be reconstructed identically (a single phase), but are labeled as different phases. This occurs if ECG leads become disconnected mid-acquisition or when the acquisition is halted prematurely due to an application crash.
3. By system design, in certain instances when a patient exhibits an arrhythmia or varying heart rate during a Step and Shoot acquisition, images from the acquisition following the heart rate variation, may be labeled in the incorrect phase.

Affected products