FDA recall Z-1302-2018

GE Healthcare · Class II · device

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.

Reason for recall

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.

Distribution

Worldwide Distribution-US Nationwide

Key facts

Status
Terminated
Initiation date
2018-02-23
Report date
2018-04-11
Termination date
2024-09-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Barrington, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1302-2018