Centricity PACS Software Version 7.0 SP0.0.4.7

Date

Aug. 3, 2022

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

GE Healthcare, LLC

Product

Centricity PACS Software Version 7.0 SP0.0.4.7

Reason

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

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.

Quantity

47 installations

Codes and lots

Model: 5831882-012, Software Version 7.0 SP0.0.4.7 GTIN: 00840682145572

Recall started

June 14, 2022

Device type

System, Image Processing, Radiological

Root cause (FDA)

Software design

What the company told customers

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.

Recall number

Z-1466-2022

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1466-2022. The agency record governs; check it and the company before acting.