Agfa HealthCare XERO Viewer Medical Imaging Software Class II Defect
Agfa Healthcare has recalled XERO Viewer imaging software due to a software defect that can cause issues with images. The defect affects approximately 110 units distributed across the US and 19 other countries.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall with no reported illnesses or injuries. While the software defect affects medical imaging functionality, the theoretical hazard without confirmed harm incidents places this at High severity per the rubric.
Plain-English summary
Agfa Healthcare NV is recalling XERO Viewer, a medical imaging software used to view and interact with medical images. The affected versions are XERO Viewer 8.1.4.100 and higher, XERO Viewer 8.2.0.000 and higher, and XERO Viewer 8.2.1.000 and higher. Approximately 110 units have been distributed.
The recall is due to a software defect that can cause issues with images. The FDA has classified this as a Class II recall, indicating a product defect that could result in adverse health consequences but for which an injury or adverse event is not likely to occur. No illnesses or injuries have been reported to date.
The affected software has been distributed throughout the United States and to 19 countries, including Australia, Belgium, Brazil, Canada, Chile, Cyprus, France, Iceland, Ireland, Italy, Kenya, Luxembourg, Netherlands, Romania, Saudi Arabia, Spain, Sweden, United Kingdom, and South Africa.
Healthcare facilities and providers using the affected versions of XERO Viewer should contact Agfa Healthcare NV for guidance on remediation or software updates.
The recalled product
- Product
- Agfa HealthCare Enterprise Imaging XERO Viewer
- Manufacturer
- Agfa Healthcare NV
- Affected units
- 110
Distribution
Distribution scope not specified by the agency.
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