Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0055-2025.
Software defect, when an image has non-square pixel spacing, the reference/localizer line is incorrectly placed on the scout image in the XERO Viewet, may display the incorrect crosshair/line position on the non-coplanar/scout image with respect to the axial slice location. Inaccurate placement of reference lines or crosshairs have potential risk of misdiagnosis or mistreatment due to unintended shifts in the display of anatomical locations.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0055-2025.
Recall ongoing. Follow firm instructions.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0055-2025.
Agfa Healthcare NV
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If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Agfa Healthcare Nv Recall FAQ
Agfa Healthcare Nv is the subject of a diagnostic devices safety report: Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-.... The notice was published on September 6, 2024 by the U.S. Food and Drug Administration (FDA). Approximately 801 units are potentially affected.