Centricity Universal Viewer - Main Unit (2018-02-06)

Starting date:

February 6, 2018

Posting date:

February 16, 2018

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-66010

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  Reason
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  Affected products

Affected products

Centricity Universal Viewer - Main Unit

Reason

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.

Affected products