The Recall Desk

Hazard

Measurement Inaccuracy recalls

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

What the numbers show

Total
65
Critical
0
Severe
4
Most recent
2025-07-02

Of the 65 measurement inaccuracy recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (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 measurement inaccuracy 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.

1–25 of 65

  • HighFDA (Devices)·Z-2018-2025·2025-07-02

    CDI OneView System BPM Probe temperature sensor measurement inaccuracy

    Terumo Cardiovascular Systems is recalling CDI OneView System BPM Probe units due to thermistor assembly errors that cause inaccurate temperature and blood gas measurements, potentially leading to inappropriate clinical decisions.

    Product
    CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1729-2025·2025-05-14

    Philips Tempus Pro Patient Monitor Software Update for Operational Issues

    Remote Diagnostic Technologies Ltd. is issuing a software update for the Philips Tempus Pro Patient Monitor due to freezing, rebooting, and potential ECG measurement accuracy issues across multiple software versions.

    Product
    Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0293-2025·2024-11-20

    Trilogy EV300 ventilator: potential flow sensor malfunction from aerosol accumulation

    Philips Respironics is recalling 34,146 Trilogy EV300 ventilators due to potential aerosol accumulation on the internal flow sensor, which could cause inaccurate ventilation measurements.

    Product
    Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200X15B, ES2200X15B, FR2200X14B, FX2200X15B, EU2200X15B, IA2200X15B, IT2200X21B, KR2200X15B, TR2200X15B, EE2200X15B. Intended for invasive and non-invasive venti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0295-2025·2024-11-20

    Ventilator Model LD2110X23B Recalled for Potential Sensor Measurement Failure

    Philips Respironics is recalling 1,322 Garbin Evo ventilators (Model LD2110X23B) worldwide due to potential aerosol accumulation that could cause inaccurate flow sensor readings, posing a risk to patient care.

    Product
    Garbin Evo. Model Number: LD2110X23B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0294-2025·2024-11-20

    Aeris EVO Ventilator May Develop Flow Sensor Fouling from Aerosols

    Philips Respironics Aeris EVO ventilators may accumulate aerosol deposits on the internal flow sensor, potentially causing inaccurate flow measurements.

    Product
    Aeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0108-2025·2024-10-23

    Boston Scientific AVVIGO+ Imaging System Grid Display Error

    Boston Scientific is recalling AVVIGO+ Multi-Modality Guidance Systems due to a software error causing incorrect grid overlay display when used with OptiCross 18 catheters, which could affect measurement accuracy.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0113-2025·2024-10-23

    Boston Scientific AVVIGO+ Guidance System Grid Mark Display Error

    Boston Scientific is recalling the AVVIGO+ Guidance System due to a software bug displaying incorrect grid marks during live imaging. The device shows 9 grid marks instead of 15, which could affect accurate vessel measurement in cardiac interventions.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities whi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2616-2024·2024-08-21

    BioButton Remote Monitoring Device Software Accuracy Issue

    A software anomaly causes the BioButton remote monitoring wearable device to report skin temperature readings slightly out of specification, affecting accurate health data collection in home and healthcare settings.

    Product
    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2325-2024·2024-07-17

    Kosmos iOS Ultrasound Software Update Due to Measurement Accuracy Bug

    Echonous Inc is recalling Kosmos ultrasound software for iOS due to a bug causing inaccurate measurements in DICOM exports, potentially leading to incorrect diagnoses.

    Product
    Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-2239-2024·2024-07-10

    Avalon Ultrasound Transducers Recalled for Inaccurate Fetal Heart Rate Monitoring

    Philips is recalling Avalon ultrasound transducers used for monitoring fetal heart rate. The device may produce inaccurate measurements when monitoring multiple fetuses, potentially delaying detection of fetal distress.

    Product
    Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1272-2024·2024-03-13

    Medical imaging software measurements incorrect in specific cases

    FUJIFILM's Synapse PACS Version 7.2.200 produces incorrect measurements when analyzing certain breast imaging scans without pixel spacing data. This measurement error could affect diagnostic accuracy.

    Product
    Synapse PACS - Version 7.2.200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0753-2024·2024-01-24

    Calibration Serum with Mis-assigned Alkaline Phosphatase Target

    Randox Calibration Serum Level 3 has an incorrect Alkaline Phosphatase target value (approximately 10% off) affecting clinical chemistry testing on RX Series instruments.

    Product
    Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0616-2024·2024-01-03

    Landauer microSTARii reader recalled for measurement inaccuracy

    Landauer microSTARii readers may provide inaccurate dosimetry measurements due to LED beam profile issues and debris formation. Inaccuracy may not be detected without regular quality control testing. 584 units affected worldwide.

    Product
    Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0209-2024·2023-11-08

    Abbott NT2000iX radiofrequency generator serviced with out-of-tolerance tool

    Abbott is recalling 34 NT2000iX radiofrequency generators that were serviced using an out-of-tolerance calibration tool, which may have provided inaccurate measurement results for capacitance failures.

    Product
    Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2557-2023·2023-09-20

    Radiation Dosimeter May Provide Inaccurate Dose Measurements

    Landauer is recalling certain nanoDot D2DNS radiation dosimeters because they may measure radiation exposure outside the specified accuracy range. Approximately 5,958 units worldwide are affected.

    Product
    Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 04217-000 (EMEA number VINLNAN003); b) 04217-KIT; c) 04217-SET; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2554-2023·2023-09-20

    Landauer nanoDot A Dosimeters Recalled for Potential Measurement Inaccuracy

    Landauer is recalling nanoDot A radiation dosimeters (Model 03501-000) because some units may measure radiation exposure outside the acceptable accuracy range. A potential non-conformance in the optical material was identified during investigation.

    Product
    nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2547-2023·2023-09-20

    Radiation Monitoring Dosimeter Potential Accuracy Error: Worldwide Landauer nanoDot Recall

    Landauer is recalling nanoDot D2DXS radiation monitoring dosimeters worldwide due to a potential non-conformance that could cause some units to measure radiation exposure outside the specified +/-5.5% accuracy range.

    Product
    nanoDot D2DXS, Model Numbers: a) 03062-1MO; b) 03062-3MO; c) 03062-OTO; d) 03062-SMO; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2541-2023·2023-09-20

    Landauer nanoDot radiation dosimeters recalled for accuracy drift

    Landauer is recalling nanoDot D2DNN radiation dosimeters because some units may have measurement accuracy outside their specified +/-5.5% range. Worldwide users should contact the manufacturer to verify device performance.

    Product
    nanoDot D2DNN, Model Numbers: a) 03053-1MO; b) 03053-1WK ; c) 03053-3MO; d) 03053-OTO; e) 03053-SMO; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2574-2023·2023-09-20

    NanoDots radiation dosimeter recalled for potential measurement accuracy issues

    Landauer is recalling NanoDots radiation monitoring dosimeters because some units may not meet specified accuracy of +/-5.5% due to a defect in the luminescence material.

    Product
    NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2563-2023·2023-09-20

    Radiation Dosimeter Recall: nanoDot D2DNN Accuracy Outside Specifications

    Landauer is recalling nanoDot D2DNN radiation dosimeters worldwide because some units may have measurement accuracy outside the specified +/-5.5% range. Approximately 36,805 units are affected.

    Product
    nanoDot D2DNN, Model Numbers: a) 18105-000; b) 18105-KIT; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2565-2023·2023-09-20

    Landauer nanoDot radiation dosimeter units recalled due to accuracy failure

    Landauer is recalling 973 radiation dosimeter units that may not accurately measure radiation exposure due to a potential defect in the light-emitting material used for dose measurement.

    Product
    Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18121-000; b)18121-KIT; c) 18121-SET; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2567-2023·2023-09-20

    Landauer nanoDot radiation dosimeters may be outside accuracy specifications

    Landauer is recalling nanoDot D2DNS radiation dosimeters that may be outside the specified +/-5.5% accuracy range. The issue involves a potential non-conformance in the optical measurement material.

    Product
    QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18130-000; b) 18130-KIT; c) 18130-SET; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2548-2023·2023-09-20

    Landauer nanoDot D2DXS Dosimeter Recall for Measurement Accuracy

    Landauer is recalling nanoDot D2DXS radiation dosimeters that may not accurately measure radiation exposure. Some units may fall outside the specified ±5.5% accuracy range due to a potential defect in the optical stimulated luminescence material.

    Product
    nanoDot D2DXS, Model Numbers: a) 03063-1MO; b) 03063-3MO; c) 03063-OTO; d) 03063-SMO; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2539-2023·2023-09-20

    Landauer nanoDot D2DNS Radiation Dosimeters Recalled for Accuracy Non-Conformance

    Landauer recalled 135 nanoDot D2DNS radiation dosimeters worldwide due to potential accuracy deviations outside the specified ±5.5% range in optical stimulated luminescence material.

    Product
    nanoDot D2DNS, for custom calibrate, OTO, Model Numbers 03034-OTO; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states