GE Healthcare, LLC 2022-08-03 Health serious FDA
Health · FDA · Recall #FDA-Z-1466-2022
Centricity PACS Software Version 7.0 SP0.0.4.7 Recall
Issued August 3, 2022 · GE Healthcare, LLC
In August 2022, GE Healthcare, LLC recalled the Centricity PACS Software Version 7.0 SP0.0.4.7, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.
What you should do
- 1 Stop using Centricity PACS Software Version 7.0 SP0.0.4.7 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact GE Healthcare, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- GE Healthcare, LLC
- Category
- Health
- Recall date
- August 3, 2022
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide distribution in the states of CO, NV, OH, PA, WA and the countries of Brazil, Canada, China, France,
- Recall number
- FDA-Z-1466-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- GE Healthcare, LLC has 14 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.