Recall Z-1885-2019— GE Healthcare, LLC

Name: FDA recall Z-1885-2019
Creator: U.S. Food and Drug Administration
Published: 2019-05-17

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2019-05-17, terminated 2023-11-20. It names one FDA 510(k) clearance: K123174. Product: Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed. Typical users of this system are authorized healthcare professionals. Centricity Universal Viewer is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information. Mammography images may only be interpreted using a monitor compliant with requirements of local regulations and must meet other technical specifications reviewed and accepted by the local regulatory agencies. Contraindications: Centricity Universal Viewer is contraindicated for the use of lossy compressed mammographic images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.. Reason: There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2019-05-17
Terminated: 2023-11-20
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K123174 — CENTRICITY PACS-IW WITH UNIVERSAL VIEWERGE Healthcare·cleared 2012-11-16

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

Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed. Typical users of this system are authorized healthcare professionals. Centricity Universal Viewer is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information. Mammography images may only be interpreted using a monitor compliant with requirements of local regulations and must meet other technical specifications reviewed and accepted by the local regulatory agencies. Contraindications: Centricity Universal Viewer is contraindicated for the use of lossy compressed mammographic images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.

Reason for recall

There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer.

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