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Terminated

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 Z-1885-2019 · Posted None

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeLLZ
Date Initiated2019-05-17
Date Terminated2023-11-20
Product Quantity50 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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123174CENTRICITY PACS-IW WITH UNIVERSAL VIEWERGE Healthcare · 2012-11-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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