Recall Z-2101-2018— GE Healthcare

Name: FDA recall Z-2101-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-25

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, initiated 2018-01-25, terminated 2023-11-02. It names one FDA 510(k) clearance: K123174. Product: Centricity PACS-IW with Universal Viewer Product Usage: 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, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.. Reason: Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer..

Recalling firm: GE Healthcare
Classification: Class II
Status: Terminated
Initiated: 2018-01-25
Terminated: 2023-11-02
Firm location: Chicago, IL, 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 Product Usage: 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, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.

Reason for recall

Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer.

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