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Terminated

Centricity PACS Software Version 7.0 SP0.0.4.7

FDA Recall Z-1466-2022 · Posted None

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeLLZ
Date Initiated2022-06-14
Date Terminated2024-01-16
Product Quantity47 installations

Reason for Recall

The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.

Firm Action

An Urgent Medical Device Correction letter was sent to customers beginning June 14, 2022. The letter informs the customer of the issue and provides safety instructions for continued use of the device. GE Healthcare will correct all affected devices via a software update. In the U.S., this letter will be sent by a traceable means. This letter will be sent to the following titles within the affected accounts: Director/Manager of Radiology, Director/Manager of Cardiology, Risk Manager/Hospital Administrator, Head of Radiology Department, Head of Cardiology Department, PACS Administrator, Director of IT Department, Head of Biomedical Engineering, Head of Imaging Informatics.

Root Cause

Software design

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of CO, NV, OH, PA, WA and the countries of Brazil, Canada, China, France, Germany, Israel, Italy, Japan, Oman, Spain, Switzerland, and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110875CENTRICITY PACSGE Healthcare · 2011-05-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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