The Recall Desk

Hazard

Patient Misidentification recalls

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

What the numbers show

Total
16
Critical
0
Severe
1
Most recent
2026-08-12

Of the 16 patient misidentification recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (6%) 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 patient misidentification 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.

1–16 of 16

  • SevereFDA (Devices)·Z-2876-2026·2026-08-12

    GE Healthcare MAC VU360 Electrocardiograph Software Recall

    GE Healthcare is recalling 163 MAC VU360 electrocardiograph units due to a software issue that may cause a previous patient's data to remain visible and be incorrectly associated with a subsequent patient.

    Product
    GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2821-2026·2026-08-05

    Bar Code Reader Wands for GEM Premier Blood Analyzers Recalled Due to Misidentification Risk

    Instrumentation Laboratory is recalling Bar Code Reader (BCR) wands used with GEM Premier 5000 and 7000 systems because they may assign patient results to the wrong patient ID.

    Product
    GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Portable blood analyzer system. Affected Accessory: Bar Code Reader (BCR) Wand Part No. 00024015859
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2553-2026·2026-07-01

    GE Healthcare AW Server Radiological Image Processing System Software Defect

    GE Healthcare is recalling the AW Server 3.2 ext. 6.5 radiological image processing system due to a software synchronization issue that may cause the wrong patient's images to be displayed without warning, potentially leading to misdiagnosis.

    Product
    GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0735-2025·2025-01-01

    Blood analyzer system recalled for patient name assignment software error

    Siemens recalled its epoc NXS Host blood analyzer due to a software malfunction that can assign incorrect patient names to test results, potentially leading to misdiagnosis or mistreatment.

    Product
    epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0739-2025·2025-01-01

    Blood Analysis System Software Error Can Assign Wrong Patient Name

    Siemens epoc NXS Host blood analysis devices have a software malfunction that may assign the wrong patient name to blood test results, potentially leading to misdiagnosis or mistreatment.

    Product
    epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or ca
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0734-2025·2025-01-01

    Blood Analysis System Recalled Due to Patient Name Assignment Software Error

    Siemens is recalling the epoc NXS Host blood analysis system due to a software defect that can incorrectly assign patient names to test results, potentially causing misdiagnosis and mistreatment.

    Product
    epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capill
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0737-2025·2025-01-01

    Blood Analysis System Software Malfunction May Assign Incorrect Patient Names

    Siemens epoc NXS Host blood analysis systems contain a software malfunction that may assign incorrect patient names to blood measurements. This could result in clinicians making treatment decisions based on the wrong patient's test results.

    Product
    epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0738-2025·2025-01-01

    Siemens Blood Analysis System Software Malfunction May Cause Patient Identification Error

    Siemens epoc NXS Host blood analysis systems are recalled due to a software malfunction that can assign incorrect patient names to blood tests, potentially leading to misdiagnosis or mistreatment.

    Product
    epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0741-2025·2025-01-01

    Siemens epoc blood analyzer software assigns incorrect patient names

    Siemens epoc NXS blood analysis system has a software defect that can incorrectly assign patient names to blood test results, potentially causing misdiagnosis or mistreatment.

    Product
    epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0321-2025·2024-11-13

    Cardiac stress testing system recalled due to duplicate patient identifiers

    The Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System may assign duplicate unique identifiers to exam files, potentially causing patient identification mismatches with their cardiac test data.

    Product
    Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2317-2024·2024-07-17

    GE Vivid Ultrasound Scanner Displays Incorrect Patient Data

    GE Vivid ultrasound systems may display incorrect patient names and demographics due to slow DICOM response times, risking patient misidentification during imaging.

    Product
    GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1072-2024·2024-02-21

    Philips ProxiDiagnost N90 X-ray System Recall for Patient Data and Security Issues

    Philips is recalling 138 U.S. units of its ProxiDiagnost N90 radiography system due to two identified issues. The system may display incorrect patient images during scan transitions, and a security vulnerability could allow unauthorized data access with physical device access.

    Product
    ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2280-2023·2023-08-09

    NanoZoomer S360MD Slide Scanner May Record Incorrect Barcode Information

    Hamamatsu's NanoZoomer S360MD slide scanner may record incorrect barcode information in the NDPi file, potentially causing pathologists to reference the wrong patient's digital slide image.

    Product
    NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managing digital slides. The NanoZoomer System creates diagnostic-quality digital images of glass slides containing formalin-fixed paraffin-embedded (FFPE) tissue. Catalog Number: C13220-01MD
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0952-2023·2023-01-18

    Medical device software bug may cause patient sample order mismatches in rare cases

    A software bug in Roche Diagnostics' cobas infinity central lab may cause orders to be mismatched to wrong patient samples under rare circumstances. The issue affects 224 US units and 2,797 devices worldwide.

    Product
    cobas infinity central lab, Material Number 07154003001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2379-2016·2016-08-17

    Merge PACS software recalled due to patient name mismatch

    Merge Healthcare is recalling PACS software versions V6.0.2.0 MR2 and earlier because patient names in the interface do not match the displayed images.

    Product
    Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1646-2014·2014-05-28

    Philips XIRIS 8.1.50.0 Recall Due to Patient Data Synchronization Error

    Philips Healthcare Informatics is recalling 5 units of XIRIS 8.1.50.0 due to a synchronization error that may display incorrect patient information.

    Product
    Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system (RIS) is a computer system that assist radiology services in the storing, manipulating and retrieving of patient information. This included patient scheduling
    Category
    Medical Device
    Distribution
    2 states