Recall Z-0226-2016— GE Healthcare

Name: FDA recall Z-0226-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-28

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, initiated 2015-09-28, terminated 2018-04-11. It names one FDA 510(k) clearance: K150420. Product: The Centricity Universal Viewer Version 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. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.. Reason: Inaccurate distance measurements with magnified projection X-ray images..

Recalling firm: GE Healthcare
Classification: Class II
Status: Terminated
Initiated: 2015-09-28
Terminated: 2018-04-11
Firm location: Barrington, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K150420 — Centricity Universal ViewerGE Healthcare·cleared 2015-05-26

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

The Centricity Universal Viewer Version 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. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.

Reason for recall

Inaccurate distance measurements with magnified projection X-ray images.

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