Agfa HealthCare Enterprise Imaging XERO Viewer
FDA device recall Z-1004-2023 · posted 2023-01-20 · Open, Classified
Recall details
- Recalling firm
- Agfa Healthcare NV
- Reason for recall
- There is a software defect that can cause issues with images.
- Action taken
- On December 5th, 2022, a customer letter ("Mandatory Product Correction Notification") was mailed to 40 United States of America affected consignees. The letter informed the customers about the issue and outlined the planned corrective actions. Acknowledgment, via email, that the information was received and understood was requested from the consignees. A Mandatory Service Bulletin was released to provide documentation to Agfa Healthcare services on how to deploy the correction for Enterprise Imaging XERO Viewer for the affected customer sites. Agfa HealthCare Service is reaching out to the affected customers to schedule and apply appropriate software correction.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- LLZ
- Quantity affected
- 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,
- Date initiated
- 2022-12-05
- Date posted
- 2023-01-20
- Location
- Mortsel, Belgium
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Enterprise Imaging XERO Viewer 8.1 (K170434) | Agfa Healthcare N.V. | 2017-07-03 |