Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and data from various imaging sources.
FDA Recall Z-0721-2023 · Posted 2022-12-16
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Recalling FirmGE Medical Systems, LLC
Recall StatusOpen, Classified
Product CodeLLZ
Date Initiated2022-10-28
Product Quantity1 unit
Reason for Recall
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.
Firm Action
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.
Root Cause
Software Manufacturing/Software Deployment
Distribution Pattern
Nationwide distribution to CA, CO, DE, FL, IA, IL, MA, MI, MN, MO, MS, MT, ND, NJ, NY, OK, OR, SD, TX, WI, WV, WY. International distribution to Austria, Brazil, France, Germany, Ghana, Ireland, Italy, Kuwait, Poland, Saudi Arabia, South Africa, Spain, Switzerland, United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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