—#173381

Product

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 product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K123174
Affected lot / code info: Product ID numbers: 4405-1-Centricity Universal Viewer-00558662 4410-1-Centricity Universal Viewer-00558656 9789-1-Centricity Universal Viewer-00558645 4408-1-Centricity Universal Viewer-00558664 4284-1-Centricity Universal Viewer-00558672 4407-1-Centricity Universal Viewer-00558652 4407-1-Centricity Universal Viewer-00558657 10227-1-Centricity Universal Viewer-00558665 9768-1-Centricity Universal Viewer-00558661 9768-1-Centricity Universal Viewer-01972254 100019-1-Centricity Universal Viewer-00558666 1045-1-Centricity Universal Viewer-00558651 101725-2-Centricity Universal Viewer-00558642 104249-1-Centricity Universal Viewer-00558667 102406-2-Centricity Universal Viewer-00558669 100064-1-Centricity Universal Viewer-00558572 102062-1-Centricity Universal Viewer-00558650 100722-1-Centricity Universal Viewer-02205220 100862-1-Centricity Universal Viewer-01444483 101272-1-Centricity Universal Viewer-00558671 4705-1-Centricity Universal Viewer-00558663 100092-1-Centricity Universal Viewer-00558648 4418-1-Centricity Universal Viewer-00558674 11580-1-Centricity Universal Viewer-00558646 10278-1-Centricity Universal Viewer-00558655 101931-1-Centricity Universal Viewer-00558569 12945-1-Centricity Universal Viewer-00558658 2403-7-Centricity Universal Viewer-00558347 2403-7-Centricity Universal Viewer-01973509 10372-1-Centricity Universal Viewer-00558654 4601-1-Centricity Universal Viewer-00558710 1696-1-Centricity Universal Viewer-00558659 1696-1-Centricity Universal Viewer-01972253 4546-1-Centricity Universal Viewer-00558670 12866-1-Centricity Universal Viewer-01448215 103246-1-Centricity Universal Viewer-00558668 269338-Centricity Universal Viewer-01453050 94767-Centricity Universal Viewer-01422997 255867-Centricity Universal Viewer-01798076 339362-Centricity Universal Viewer-01970967 X13479-Centricity Universal Viewer-00043936 126292-Centricity Universal Viewer-01282277 HC3062-Centricity Universal Viewer-01462397 HC3062-Centricity Universal Viewer-01462397 JP-ANKLESHWAR-PACS-IW UV Frontend-01821488 MANGALAM-MEH-PACS-IW UV Frontend-01821440 329052-Centricity Universal Viewer-01443407 ZA2533-Centricity Universal Viewer-00116577 SiteID-Centricity Universal Viewer-01998839 YP3150-Centricity Universal Viewer-01639018

Why it was recalled

There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

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

Timeline

Recall initiated: 2019-05-17
Terminated: 2023-11-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #173381. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.