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Agfa HealthCare Enterprise Imaging XERO Viewer

FDA Recall #Z-1004-2023 — Class II — December 5, 2022

Recall #Z-1004-2023 Date: December 5, 2022 Classification: Class II Status: Ongoing

Product Description

Agfa HealthCare Enterprise Imaging XERO Viewer

Reason for Recall

There is a software defect that can cause issues with images.

Recalling Firm

Agfa Healthcare NV — Mortsel, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product 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

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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