Product Wiki · Recalls · Health Canada — Medical Devices

Centricity Universal Viewer - Main Unit (2018-02-06) — recall 57756

Health Canada — Medical Devices · Canada · 2018-02-16 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
57756
Date of alert
2018-02-16
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: The following issue is being addressed by GE Healthcare File No. FMI 85442. GE Healthcare has recently become aware that a database handling error could occur during the image acquisition process affecting the completeness of acquired images with Centricity Universal Viewer running on a PACS-IW foundation. There is a potential that one or more "image series" (i.e. all images within an image set) may be missing from an exam without a user warning displayed in the Viewer. While this is rare, this can occur with imaging studies that consist of a very small number of images per series. E.g. CR Thorax exam with 1 image per series. There have been no injuries reported as a result of this issue.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/centricity-universal-viewer-ma

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