Centricity Universal Viewer 7.0 recall: Software Issue
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Why was Centricity Universal Viewer 7.0 recalled?
A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterprise Archive (EA) or another Vendor Neutral Archive (VNA).
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?
Centricity Universal Viewer, Software Versions 7.0 SP0.0.4.5 and 7.0 SP0.0.5 GTIN 00840682145794
- Product
- Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 49
- Distribution
- AR, IL, ME, MS, NE, NJ, NY, and TN Belgium, Canada, Costa Rica, France, Germany, India, Japan, Korea, Kuwait, Saudi Arabia, Singapore, Switzerland, Switzerland, Turkey and United Kingdom
- Recall date
- October 13, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)