Agfa HealthCare Enterprise Imaging XERO Viewer recall: Software Issue
Agfa HealthCare Enterprise Imaging XERO Viewer
Why was Agfa HealthCare Enterprise Imaging XERO Viewer recalled?
There is a software defect that can cause issues with images.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
Affected software versions include: XERO Viewer 8.1.4.100 or higher XERO Viewer 8.2.0.000 or higher XERO Viewer 8.2.1.000 or higher UDI/DI: 05400874000710
- Product
- Agfa HealthCare Enterprise Imaging XERO Viewer
- Recalling firm
- Agfa Healthcare NV
- Quantity
- 110 units
- Distribution
- Distribution throughout US OUS distribution to Australia, Belgium, Brazil, Canada, Chile, Cyprus, France, Iceland, Ireland, Italy, Kenya, Luxembourg, Netherlands, Romania, Saudi Arabia, Spain, Sweden, United Kingdom, South Africa
- Recall date
- February 1, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)