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Agfa Healthcare NV FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medicalClass IISep 6, 2024Software defect, when an image has non-square pixel spacing,
Agfa HealthCare Enterprise Imaging XERO ViewerClass IIDec 5, 2022There is a software defect that can cause issues with images

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