Centricity PACS Medical Imaging System Image Acquisition and Synchronization Failures

Plain-English summary

GE Healthcare has recalled the Centricity PACS-IW with Universal Viewer, a medical imaging system used to display and manage medical images, including mammograms, and imaging data from various sources.

The recalled system experiences image acquisition failures and synchronization failures with the Centricity Enterprise Archive. These failures affect the software version 5.0.x identified by product code 2068177-001.

The recall affects 392 devices worldwide: 219 in the United States and 173 distributed internationally. Affected U.S. states include Alaska, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Texas, Utah, Washington, Wisconsin, West Virginia, and Wyoming. International distribution includes Austria, Brazil, Canada, France, Germany, Ghana, India, Ireland, Israel, Italy, Kuwait, Netherlands, Panama, Poland, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, United Kingdom, and Uruguay.

The recalled product

Product

Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources.

Manufacturer

GE Healthcare, LLC

Category

Medical Device — Medical Imaging System / PACS

Hazard

• image-acquisition-failure
• synchronization-failure
• software-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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