Centricity PACS Software Version 7.0 SP0.0.4.7 recall
Centricity PACS Software Version 7.0 SP0.0.4.7
Why was Centricity PACS Software Version 7.0 SP0.0.4.7 recalled?
The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model: 5831882-012, Software Version 7.0 SP0.0.4.7 GTIN: 00840682145572
- Product
- Centricity PACS Software Version 7.0 SP0.0.4.7
- Recalling firm
- GE Healthcare, LLC
- 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.
- Recall date
- August 3, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)