The Recall Desk

Hazard

Inaccurate Diagnostic Data recalls

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

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2021-02-10

Of the 5 inaccurate diagnostic data 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 inaccurate diagnostic data 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.

1–5 of 5

  • HighFDA (Devices)·Z-0944-2021·2021-02-10

    Philips EPIQ Ultrasound Systems Recalled for Inaccurate Doppler Flow Visualization

    Philips is recalling EPIQ Diagnostic Ultrasound Systems because the Image Boost feature may cause inaccurate color and Doppler flow visualization when used with specific transducers.

    Product
    Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi. MOD EPIQ Elite DIAGNOSTIC ULTRASOUND SYSTEM; Rx Only 100-240V~50/60 Hz, 600 VA MOD EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM; GMDN 40761, Rx Only, 100-2
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-1839-2019·2019-06-26

    GE Healthcare Recalls Vscan Extend Ultrasound Devices Due to EF Calculation Bias

    GE Healthcare is recalling 119 Vscan Extend ultrasound devices because the LVivo EF app may overestimate ejection fraction values, potentially affecting clinical assessments.

    Product
    LVivo EF app on Vscan Extend. Sold under the following product names: a. Vscan Extend Dual DICOM, Model Numbers H41212ZA, H41212RN; b .Vscan Extend Dual USB, Model Number H41212RK; c. Vscan Extend Dual Wi-Fi, Model Numbers H41212YZ, H41212RL; d. Vscan Extend
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2852-2016·2016-09-28

    Siemens Syngo.x Software Recalled for Incorrect Volume Calculations

    Siemens Medical Solutions is recalling 338 Syngo.x PACS systems because a software error caused volume calculations for prostate and liver to be too high.

    Product
    Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2477-2015·2015-09-02

    Nidek OPD-Scan III Recall for Software Aberration Calculation Error

    Nidek Inc is recalling 3,836 OPD-Scan III Refractive Power/Corneal Analyzers due to a software bug that incorrectly calculates high-order aberrations.

    Product
    OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01. Opthalmic: The OPD-Scan III is a diagnostic instrument that is indicated for use f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1678-2014·2014-06-11

    Philips IntelliSpace Portal Software Recall for SPECT Reconstruction Errors

    Philips Medical Systems is recalling IntelliSpace Portal software because SPECT reconstructions may lack scatter correction or apply resolution recovery incorrectly.

    Product
    IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips Medical Systems. A medical software system for diagnostic imaging data viewing.
    Category
    Medical Device
    Distribution
    Distributed nationwide