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 Z-1886-2019 · Posted None
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Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeLLZ
Date Initiated2019-05-17
Date Terminated2023-11-20
Product Quantity292 units
Reason for Recall
There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer.
Firm Action
The firm issued a medical device correction notice on 05/17/2019. The letter stated the safety issue and provided additional instructions on the use of the system until a service engineer installs the correction. A firm representative will contact the consignee to arrange for the installation.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - US Nationwide Austria, Belgium, Brazil Canada Colombia France Germany Ghana India Ireland Israel Italy Kuwait Mexico Netherlands Panama Poland Qatar Russia Saudi Arabia Slovenia South Africa Spain Switzerland Turkey United Arab Emirates United Kingdom Uruguay
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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