Product Wiki · Recalls · Health Canada — Medical Devices

IMAGE SUITE 3.0/4.0 SOFTWARE (2016-04-20) — recall 55287

Health Canada — Medical Devices · Canada · 2016-05-16 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
55287
Date of alert
2016-05-16
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Carestream has identified a software issue that if the image suite software receives Computed Tomography (CT) and Magnetic Resonance (MR) images with the image orientation (patient) tag specified, and the overlay is configured to display this tag, the L (left) and R (right) and A (anterior) and P (posterior) overlay text could be displayed reversed.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/image-suite-3040-software-2016

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