GE Healthcare Recalls Centricity Universal Viewer for Missing Image Warning
GE Healthcare is recalling 292 units of the Centricity Universal Viewer because it may fail to warn users when medical images are missing from exams.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used for diagnostic imaging where a software defect could lead to the review of incomplete data. This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' as no specific injuries or illnesses are cited in the source text.
Plain-English summary
GE Healthcare, LLC is recalling 292 units of the Centricity Universal Viewer with PACS-IW foundation 6.0 (Model number 2090255-001). The device is used to display medical images, including mammograms, and data from various imaging sources.
The recall was initiated because there is a potential that one or more images or image series may be missing from exams without a warning being displayed in the viewer. This lack of warning could result in incomplete medical image reviews.
The affected units were distributed worldwide, including in the United States and numerous international locations such as Canada, the United Kingdom, Germany, and India. Healthcare facilities should contact GE Healthcare for instructions on how to resolve the issue.
The recalled product
- Product
- 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, com
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 292
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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