FDAFDA · Food and drugs·Recall number Z-1466-2022
Centricity PACS Software Version 7.0 SP0.0.4.7
Published August 3, 2022 · Recall initiated: June 14, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- 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
- Model: 5831882-012, Software Version 7.0 SP0.0.4.7 GTIN: 00840682145572
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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