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Sources: EU EUDAMED, US FDA
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FDA Recall
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Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed. Typical users of this system are authorized healthcare professionals. Centricity Universal Viewer is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information. Mammography images may only be interpreted using a monitor compliant with requirements of local regulations and must meet other technical specifications reviewed and accepted by the local regulatory agencies. Contraindications: Centricity Universal Viewer is contraindicated for the use of lossy compressed mammographic images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code LLZ·May 17, 2019
Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code LLZ·May 17, 2019
Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system
FDA Recall
Open, Classified
·Surgical Theater Inc·Product code LLZ·September 16, 2025
Intelerad InteleShare software, with ProViewer component
FDA Recall
Open, Classified
·DICOM Grid, Inc.·Product code LLZ·November 18, 2025