GE Medical Systems, LLC Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging sources. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can result in a delay in reading the study.

Recommended Action

Per FDA guidance

GE Healthcare notified consignees on about 10/28/2022 via letter titled, "URGENT MEDICAL DEVICE CORRECTION - UPDATE." Consignees were instructed that the device can continued being used by following these instructions: 1) When a study is not present on the Study List, contact a GE Healthcare Service Representative for assistance in recovering the study. 2) In situations where study interpretation is time sensitive, interpret the study at the scanning unit or plan for an alternate means of reading studies for emergent cases. GE Healthcare will contact consignees to arrange for the correction. Consignees were also instructed to complete and return the acknowledgement form.