Enterprise Imaging XERO Viewer 8Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05400874000710), received between Aug 27, 2024 and Aug 28, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Application Program Problem: Parameter Calculation Error” (2 reports).

2 FDA recall records name this device's identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Sep 6, 2024Open, Classified

   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.

   Z-0055-2025 · Root cause: Software design · Recall details · FDA record ↗

2. Dec 5, 2022Open, Classified

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

   Z-1004-2023 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2024Application Program Problem: Parameter Calculation Error; Application Program Problem: Parameter Calculation Error

  ON (B)(6) 2024, A CUSTOMER REPORTED TO AGFA HEALTHCARE THAT WHILE USING THE XERO VIEWER, REFERENCE/LOCALIZER LINE ON THE CORONAL SCOUT IMAGE, REPRESENTING THE AXIAL CT SLICE POSITION DISPLAYED ON THE OTHER VIEWPORTS, WAS OFFSET BY 20MM FROM THE ACTUAL POSITION. AS A RESULT OF THIS ISSUE, A SPINAL SURGERY WAS PERFORMED ON THE WRONG VERTEBRA. EVENT DETAILS: ON (B)(6) 2024 AT 12:37, A PATIENT UNDERWENT A CT OF THE LUMBAR SPINE BY REQUEST OF THE NEUROSURGEON TO DETERMINE THE SOURCE OF LOWER BACK PAIN THAT WAS RADIATING INTO THE RIGHT LEG. THE STUDY WAS REPORTED ON (B)(6) 2024 AT 13:00 BY THE RADIOLOGIST WHO IDENTIFIED A RIGHT SIDED FORAMINAL EXTRUSION AT THE L5/S1 LEVEL AND A POSSIBLE CONFLICT WITH THE L5 NERVE ROOT. THAT SAME DAY THE PATIENT UNDERWENT A POSTERIOR FORAMINOTOMY AT L4/L5 WHICH IS IN CONTRAST TO WHAT THE RADIOLOGIST REPORT IDENTIFIED IN RELATION TO THE RIGHT SIDED FORAMINAL EXTRUSION AT THE L5/S1 LEVEL. THIS WAS DUE TO REFERENCE LINE ON THE LATERAL SCOUT IMAGE, REPRESENTING THE AXIAL CT SLICE POSITION DISPLAYED ON THE OTHER IMAGE VIEWPORTS, WAS OFFSET 20MM (AT L4/L5) FROM THE ACTUAL CORRECT POSITION (AT L5/S1). AS THE PATIENT'S LOWER BACK PAIN DID NOT SUBSIDE, AN ADDITION

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20084885 ↗
• InjuryAug 27, 2024Application Program Problem: Parameter Calculation Error; Application Program Problem: Parameter Calculation Error

  ON AUGUST 7 2024, A CUSTOMER REPORTED TO AGFA HEALTHCARE THAT WHILE USING THE XERO VIEWER, REFERENCE/LOCALIZER LINE ON THE CORONAL SCOUT IMAGE, REPRESENTING THE AXIAL CT SLICE POSITION DISPLAYED ON THE OTHER VIEWPORTS, WAS OFFSET BY 20MM FROM THE ACTUAL POSITION. AS A RESULT OF THIS ISSUE, A SPINAL SURGERY WAS PERFORMED ON THE WRONG VERTEBRA. EVENT DETAILS: ON (B)(6) 2024 AT 12:37, A PATIENT UNDERWENT A CT OF THE LUMBAR SPINE BY REQUEST OF THE NEUROSURGEON TO DETERMINE THE SOURCE OF LOWER BACK PAIN THAT WAS RADIATING INTO THE RIGHT LEG. THE STUDY WAS REPORTED ON JULY 24, 2024 AT 13:00 BY THE RADIOLOGIST WHO IDENTIFIED A RIGHT SIDED FORAMINAL EXTRUSION AT THE L5/S1 LEVEL AND A POSSIBLE CONFLICT WITH THE L5 NERVE ROOT. THAT SAME DAY THE PATIENT UNDERWENT A POSTERIOR FORAMINOTOMY AT L4/L5 WHICH IS IN CONTRAST TO WHAT THE RADIOLOGIST REPORT IDENTIFIED IN RELATION TO THE RIGHT SIDED FORAMINAL EXTRUSION AT THE L5/S1 LEVEL. THIS WAS DUE TO REFERENCE LINE ON THE LATERAL SCOUT IMAGE, REPRESENTING THE AXIAL CT SLICE POSITION DISPLAYED ON THE OTHER IMAGE VIEWPORTS, WAS OFFSET 20MM (AT L4/L5) FROM THE ACTUAL CORRECT POSITION (AT L5/S1). AS THE PATIENT'S LOWER BACK PAIN DID NOT SUBSIDE, AN ADDI

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20080238 ↗