Home / Recalls / Agfa Healthcare NV / Z-0055-2025

Z-0055-2025 Class II Ongoing

Recalled by Agfa Healthcare NV — Mortsel

Recall Details

Product Type
Devices
Report Date
October 16, 2024
Initiation Date
September 6, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
801 units

Product Description

Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data . Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, 8.1, 8.1.1, 8.1.2, 8.1.3,8.1.4, 8.2.0.000, 8.2.1.000, 8.2.2.000, 8.3.0.000, 8.3.1.000, 8.3.2.000, 8.4.0.000, 8.4.1.000 (including all SU s and HF s)

Reason for Recall

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.

Distribution Pattern

US Nationwide distribution. Foreign: Argentina, Australia, Belgium, Chile, Canada, Colombia, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Georgia, Greece, Hong Kong, Iceland, Ireland, Italy, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Luxembourg, Mexico, Netherlands, Nicaragua, Norway, Oman, Pakistan, Peru, Poland, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Tanzania, Tunisia, United Arab Emirates, United Kingdom

Code Information

UDI-DI: 05400874000710 Software Versions affected: All versions of Enterprise Imaging XERO Viewer are affected 8.1.2 or higher 8.1.4 or higher 8.2.0.100 or higher 8.2.2.000 or higher 8.3.2.000 or higher 8.4.0.000 or higher Enterprise Imaging XERO Viewer main version streams 8.4.0, 8.4.1, 8.3.2, 8.3.1, 8.3.0, 8.2.2, 8.2.1, 8.2.0, 8.1.5, 8.1.4, 8.1.3, 8.1.2, 8.1.1, 8.1, 8.0.1, 8.0.0, ICIS View 2014.1, ICIS View 2014.2

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  • Z-2061-2015 Class II — IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archivin (June 26, 2015)
  • Z-1745-2015 Class II — AGFA DX-D 100 is a mobile digital radiography x-ray system (May 29, 2015)