Recall Z-1302-2018— GE Healthcare

Name: FDA recall Z-1302-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-23

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, initiated 2018-02-23, terminated 2024-09-30. It names one FDA 510(k) clearance: K082318. 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: 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..

Recalling firm: GE Healthcare
Classification: Class II
Status: Terminated
Initiated: 2018-02-23
Terminated: 2024-09-30
Firm location: Barrington, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K082318 — CENTRICITY PACS IWGe Healthcare Dynamic Imaging Solutions·cleared 2008-08-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.