Centricity PACS-IW (2018-02-23)

Starting date:

February 23, 2018

Posting date:

March 19, 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-66182

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  Reason
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  Affected products

Affected products

Centricity PACS-IW

Reason

A database handling error could occur during the image acquisition process affecting the completeness of acquired images with Centricity PACS-IW. 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 indication to the user. 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