The Recall Desk

Hazard

Medical Record Error recalls

4 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2025-03-26

Of the 4 medical record error recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all medical record error recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–4 of 4

  • HighFDA (Devices)·Z-1392-2025·2025-03-26

    Medical Device Software May Merge Patient Records Without Notification

    Brainlab's Origin Data Management software versions 3.1.0 through 3.2.1 may automatically merge patient records from unrelated individuals without user notification, creating a risk of incorrect patient data being used in clinical care.

    Product
    Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1501-2023·2023-05-10

    Medical Image Viewer May Mismatch Patient Study Records

    GE Healthcare's Centricity Universal Viewer can mismatch patient information when correcting patient or study data, affecting 329 units distributed worldwide.

    Product
    Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers: a) 2088026-003, b) 2088026-026, c) 2088026-032, d) 2088026-043, e) 2088026-044, f) 2088026-115, g) 2088026-132, h) 2088026-306, i) 2088026-308, j) 2088026-406, k) 2088026-506, l) 20
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1502-2023·2023-05-10

    Radiological imaging system may mismatch patient records

    GE Healthcare's Centricity PACS-IW radiological system can mismatch information between patients when correcting patient or study data. No illnesses reported.

    Product
    Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009, d) 2049587-011, e) 2049587-012, f) 2049587-015, g) 2052829-001, h) Not applicable; Radiological Image Processing System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1927-2021·2021-06-30

    Cardiac assessment system may display test reports in wrong patient records

    GE Healthcare's Case Cardiac Assessment System and CardioSoft diagnostic application may display one patient's cardiac test report in another patient's medical record under certain conditions. No patient injuries have been reported.

    Product
    Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application
    Category
    Medical Device
    Distribution
    Distributed nationwide