—#194640

Product

Centricity PACS Software Version 7.0 SP0.0.4.7

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K110875
Affected lot / code info: Model: 5831882-012, Software Version 7.0 SP0.0.4.7 GTIN: 00840682145572

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

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.

Timeline

Recall initiated: 2022-06-14
Terminated: 2024-01-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #194640. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.