Z-1466-2022 Class II Terminated
FDA device recall Z-1466-2022 was initiated by GE Healthcare, LLC on Jun 14, 2022 and is designated Class II. Reason for recall: The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams. The recall status is terminated (terminated Jan 16, 2024). Affected quantity: 47 installations.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 3, 2022
- Initiation Date
- Jun 14, 2022
- Termination Date
- Jan 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 47 installations
Product Description
Centricity PACS Software Version 7.0 SP0.0.4.7
Reason for Recall
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.
Code Information
Model: 5831882-012, Software Version 7.0 SP0.0.4.7 GTIN: 00840682145572
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1466-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026