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GE Healthcare recalls GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW
Recalled April 11, 2018 · FDA recall Z-1302-2018 · GE Healthcare
Hazard
A database handling error could occur during the image acquisition process affecting the completeness of acquired images with Centricity PACS-IW. There is a potential that one or more image series (i.e. all images within an image set) may be missing from an exam without indication to the user. While this is rare, this can occur with imaging studies that consist of a very small number of images per series. E.g. CR Thorax exam with 1 image per series. · FDA Class II
Units
569 units
Sold at
Worldwide Distribution-US Nationwide
Description
A database handling error could occur during the image acquisition process affecting the completeness of acquired images with Centricity PACS-IW. There is a potential that one or more image series (i.e. all images within an image set) may be missing from an exam without indication to the user. While this is rare, this can occur with imaging studies that consist of a very small number of images per series. E.g. CR Thorax exam with 1 image per series.
Product
GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Manufacturer(s)
GE Healthcare
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →