The Recall Desk

Hazard

Measurement Error recalls

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

What the numbers show

Total
163
Critical
0
Severe
10
Most recent
2026-05-06

Of the 163 measurement 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 10 (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 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.

26–50 of 163

  • HighFDA (Devices)·Z-1220-2026·2026-02-04

    Ingenia 3.0T systems recalled over elastography stiffness value errors

    Philips North America is recalling 24 units of the Ingenia 3.0T MR system because exported MR Elastography stiffness maps may show stiffness value errors.

    Product
    BEAR Implant. Model Number: 1000.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1210-2026·2026-02-04

    Ingenia Ambition X systems recalled over elastography stiffness value errors

    Philips North America is recalling 21 units of the Ingenia Ambition X because exported MR Elastography stiffness maps may show stiffness value errors.

    Product
    Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1216-2026·2026-02-04

    SmartPath dStream upgrades recalled over elastography stiffness value errors

    Philips North America is recalling 3 units of the SmartPath to dStream for XR and 3.0T because exported MR Elastography stiffness maps may show stiffness value errors.

    Product
    SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1214-2026·2026-02-04

    MR 7700 upgrades recalled over elastography stiffness value errors

    Philips North America is recalling 6 units of the Upgrade to MR 7700 because exported MR Elastography stiffness maps may show stiffness value errors.

    Product
    Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1215-2026·2026-02-04

    SmartPath dStream 3.0T upgrades recalled over elastography stiffness errors

    Philips North America is recalling 1 unit of the SmartPath to dStream for 3.0T because exported MR Elastography stiffness maps may show stiffness value errors.

    Product
    SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1212-2026·2026-02-04

    Ingenia Elition X systems recalled over elastography stiffness value errors

    Philips North America is recalling 31 units of the Ingenia Elition X MR system because exported MR Elastography stiffness maps may show stiffness value errors.

    Product
    Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0941-2026·2025-12-24

    Imaging viewer software recalled over inaccurate length measurement values

    DICOM Grid is recalling 924 units of Intelerad InteleShare software because a bug can produce inaccurate length measurement tool values that could lead to misdiagnosis.

    Product
    Intelerad InteleShare software, with ProViewer component
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-2297-2025·2025-08-20

    3mensio workstation clock measurements may place stent graft fenestrations incorrectly

    3mensio Workstation (Vascular Fenestrated) software is being recalled because changing the 12h position of a single clock does not update other clock measurements, which may place stent graft fenestrations incorrectly. 501 units affected.

    Product
    3mensio Workstation (Vascular Fenestrated) software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2014-2025·2025-07-09

    Servo-n ventilators may measure patient circuit compliance inaccurately

    The Servo-n Ventilator System is being recalled because patient circuit compliance may be measured inaccurately during the patient circuit test. 7,688 units affected.

    Product
    Servo-n Ventilator System. Model Number: 6694800.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2013-2025·2025-07-09

    Servo-u ventilators may measure patient circuit compliance inaccurately

    The Servo-u Ventilator System is being recalled because patient circuit compliance may be measured inaccurately during the patient circuit test. 874 units are affected.

    Product
    Servo-u Ventilator System. Model Number: 6688600.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2015-2025·2025-07-09

    Servo-u MR Ventilator System inaccurate patient circuit compliance measurement

    Servo-u MR Ventilator System (Model 6888800) may measure patient circuit compliance inaccurately due to incorrect pre-use leakage testing and incorrect active humidifier use.

    Product
    Servo-u MR Ventilator System. Model Number: 6888800.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1807-2025·2025-05-28

    TRUE 3D VIEWER SYSTEM displays medical images with incorrect orientation

    Echopixel's TRUE 3D VIEWER SYSTEM may display imaging data with incorrect orientation (left/right/superior/inferior/anterior/posterior), which could lead to inaccurate measurements during clinical use.

    Product
    TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health care professionals HCPs and is intended to assist the clinician who is responsible for making all patient management decisions. The True 3D V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1685-2025·2025-05-07

    epoc BGEM Crea Test Card for Blood Analysis System recalled

    Siemens Healthcare Diagnostics is recalling epoc BGEM Crea Test Card (25 pk) units due to discrepant high pH results in samples with higher injection volumes. The recall affects 5,207 units distributed nationwide and internationally.

    Product
    epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736382; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0902-2025·2025-01-22

    VITROS DGXN Slides Recalled Due to Hemoglobin Interference in Digoxin Measurement

    VITROS DGXN Slides are recalled because hemoglobin can interfere with digoxin measurement, producing artificially low results. Approximately 1,541 units were distributed in the US and internationally.

    Product
    Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Applicable Product Description: The VITROS DGXN Slide is a multilayered, analytical element coated on a polyester support. Digoxi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0901-2025·2025-01-22

    Digoxin Test Slides May Report Inaccurately Due to Hemoglobin Interference

    QUIDEL ORTHO is recalling VITROS DGXN test slides because hemoglobin can interfere with digoxin measurements at lower-than-expected levels, potentially causing inaccurate test results.

    Product
    Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Applicable Product Description: The VITROS DGXN Slide is a multilayered, analytical element coated on a polyester support. Digoxi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0767-2025·2025-01-01

    Siemens magnesium reagent cartridges recalled for false measurement results

    Siemens is recalling two lots of Magnesium Flex reagent cartridges due to potential falsely low magnesium measurements. The intermittent error may not be detected by standard quality control procedures.

    Product
    Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0201-2025·2024-10-30

    Blood Sample Pressure Kit Recalled for Monitoring Defects

    Smiths Medical recalls the medex TranStar KIDS KIT blood sample kit due to manufacturing defects in the pressure transducer that may cause inaccurate or interrupted pressure monitoring, or prevent proper device calibration.

    Product
    medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0205-2025·2024-10-30

    Smiths Medical SurgiVet pressure transducer recalled for monitoring failures

    Smiths Medical is recalling SurgiVet Advisor Tech Accessories due to manufacturing defects in the pressure transducer that may cause inaccurate, interrupted, or failed pressure monitoring.

    Product
    smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0182-2025·2024-10-30

    medex TranStar Pressure Transducer Recall Due to Manufacturing Defect

    Smiths Medical recalls medex TranStar surgical pressure transducers worldwide due to manufacturing defects that may cause inaccurate or interrupted pressure monitoring.

    Product
    medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0095-2025·2024-10-23

    Boston Scientific AVVIGO+ Imaging System Grid Overlay Display Error

    A software anomaly in the Boston Scientific AVVIGO+ Multi-Modality Guidance System causes an incorrect grid overlay display when used with certain catheters. The wrong overlay may lead to incorrect measurement references during imaging procedures.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO INTEGRATED KIT; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0111-2025·2024-10-23

    Boston Scientific AVVIGO+ System Grid Overlay Display Software Error

    Boston Scientific is recalling the AVVIGO+ Multi-Modality Guidance System due to a software error that displays an incorrect 9-grid overlay instead of the correct 15-grid overlay in Live or Record mode, affecting measurement accuracy with OptiCross 18 catheters.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + MOB Z UPGRADE JP; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3169-2024·2024-09-25

    Siemens Atellica Microalbumin Diagnostic Test Kits Recalled for Measurement Error

    Siemens Healthcare Diagnostics is recalling Atellica CH and ADVIA Chemistry Microalbumin test kits worldwide because they may not properly measure microalbumin in urine samples, potentially causing falsely low results that could delay diagnosis of kidney disease.

    Product
    Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atellica CI Analyzers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1926-2024·2024-06-05

    Philips Hemodynamic Application software pressure wave data synchronization defect

    Philips Interventional Hemodynamic Application software versions 1.2.0–1.3.1 may not correctly synchronize pressure wave data when acquiring measurements from two devices simultaneously.

    Product
    Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1599-2024·2024-05-01

    ACUSON Juniper ultrasound systems display incorrect cardiac measurements

    Siemens ACUSON Juniper ultrasound systems may display the wrong cardiac measurement value when configured to show minimum or maximum values, potentially leading to misdiagnosis.

    Product
    ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF: 11653093, running software version VA10x with DICOM SR Cardiac option, from VB10A to VB10G, VB11A, VB11B, VB30B and VB30C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1304-2024·2024-03-27

    Siemens DCA HbA1c Reagent Kit Recalled for Inaccurate Test Results

    Siemens is recalling its DCA HbA1c Reagent Kit because the device displays falsely elevated readings without alerting the user. This could lead to incorrect patient management of glucose levels.

    Product
    DCA Systems HbA1c Reagent Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide