FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: Centricity PACS Software Version 7.0 SP0.0.4.7
- Recall number
- Z-1466-2022
- Recalling firm
- GE Healthcare, LLC
- Product
- Centricity PACS Software Version 7.0 SP0.0.4.7
- Status
- Terminated
- Initiated
- 2022-06-14
- Posted
- not on file
- Terminated
- 2024-01-16
- Reason
- The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.
- Root cause
- Software design
- 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.
- Quantity
- 47 installations
- Distribution
- 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.
- Lot, serial or model codes
- Model: 5831882-012, Software Version 7.0 SP0.0.4.7 GTIN: 00840682145572
- 510(k) numbers
- ["K110875"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28