Centricity recallZ-1466-2022 · GE Healthcare, LLC · initiated Jun 14, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Healthcare, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Software design
What the company is doing
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 details
- Recall number
- Z-1466-2022
- Status
- Terminated
- Initiated by the company
- Jun 14, 2022
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 47 installations
- Product code
- LLZ
- FDA submissions
- K110875
- 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.
Product description
Centricity PACS Software Version 7.0 SP0.0.4.7
Code information (models, lots, serial numbers)
Model: 5831882-012, Software Version 7.0 SP0.0.4.7 GTIN: 00840682145572
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Centricity CPACS 7.0Ge Healthcare · System, image processing, radiological3 recalls0 reports
Product lines
Other devices under the same FDA submission
5 devices cleared under K110875 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Centricity CPACS 6.0Ge Healthcare · System, image processing, radiological3 recalls0 reports
- Centricity CPACS 7.0Ge Healthcare · Laparoscope, general & plastic surgery2 recalls1 report
- Centricity CPACS 4.0Ge Healthcare · System, image processing, radiological2 recalls0 reports
- Centricity CPACS RA1000 6.0Ge Healthcare · Laparoscope, general & plastic surgery1 recall0 reports
- Centricity CPACS RA1000 4.0Ge Healthcare · System, image processing, radiological1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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