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.

126–150 of 163

  • HighFDA (Devices)·Z-1113-2019·2019-04-17

    Siemens Medical Solutions Recalls syngo.via Cardiac Planning Software

    Siemens Medical Solutions is recalling syngo.via syngo.CT Cardiac Planning software due to a potential risk of incorrect measurements during TAVI planning procedures.

    Product
    syngo.via syngo.CT Cardiac Planning, Model Number 10496180 Product Usage: Syngo.CT Cardiac Planning and syngo CT. Cardiac Function are image analysis software packages for evaluating cardiac CT angiography (CTA) volume sets. The software packages are designed to support the p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1112-2019·2019-04-17

    Siemens syngo.CT Cardiac Function Software Recalled for TAVI Measurement Risk

    Siemens is recalling syngo.CT Cardiac Function software due to a potential risk of wrong measurement in the annulus plane during TAVI planning.

    Product
    syngo.via syngo.CT Cardiac Function, Model Number 10496180 Product Usage: Syngo.CT Cardiac Planning and syngo CT. Cardiac Function are image analysis software packages for evaluating cardiac CT angiography (CTA) volume sets. The software packages are designed to support the p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0208-2019·2018-10-31

    DePuy Mitek Screw and Washer Depth Gauge Recalled for Design Offset

    DePuy Mitek is recalling 401 Mitek Screw and Washer Depth Gauges because a design offset causes readings to be approximately 3.2mm shorter than the actual bone hole length.

    Product
    Mitek Screw and Washer Depth Gauge, Product Code 219024
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2834-2018·2018-08-29

    Liebel-Flarsheim Direct Digital Imaging System Recalled for Software Display Discrepancy

    Liebel-Flarsheim is recalling 28 Direct Digital Imaging Systems due to a software issue causing significant discrepancies between display and dosimeter readings in pediatric modes.

    Product
    Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics, endourolog
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-2247-2018·2018-06-27

    Synthes Graphic Case F/7.3mm Cannulated Screw Set Recalled for Measurement Error

    Synthes (USA) Products LLC is recalling three units of the Graphic Case F/7.3mm Cannulated Screw Set because the included gauges measure screws 5.41mm shorter than their actual length.

    Product
    Part no. 690.380, Graphic Case F/7.3mm Cannulated Screw Set
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2246-2018·2018-06-27

    Synthes Graphic Case F/6.5mm Cannulated Screw Set Recalled for Measurement Error

    Synthes (USA) Products LLC is recalling four units of the Graphic Case F/6.5mm Cannulated Screw Set because the screw gauges measure 5.41mm shorter than the actual screw length.

    Product
    Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2245-2018·2018-06-27

    Synthes Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set Recalled

    Synthes (USA) Products LLC is recalling 7 units of a combined cannulated screw set because the included gauges measure screws 5.41mm shorter than actual length.

    Product
    Part no. 690.375, Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2186-2018·2018-06-20

    Roche Recalls Accu-Chek Performa Test Strips Due to Potential Measurement Errors

    Roche Diabetes Care is recalling Accu-Chek Performa test strips because they may produce biased results or fail to detect blood samples, potentially leading to incorrect user actions.

    Product
    Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001 Product Usage: The Accu-Chek Performa test strips are for use with the Accu-Chek Performa meter to quantitatively measure glucose (sugar) in venous whole blood or fresh capillary whole blo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0565-2018·2018-02-21

    C.R. Bard Recalls CritiCore Monitors Due to Measurement and Alarm Failures

    C.R. Bard is recalling 343 CritiCore monitors because they may experience urine output and temperature measurement fluctuations and alarm errors.

    Product
    BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series The CritiCore(R) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1923-2017·2017-05-10

    Merge Healthcare Recalls Schiller CO2 Sensors Due to Alarm Bias

    Merge Healthcare is recalling 23 Schiller CO2 sensors that may display false clogging alarms, potentially adding bias to CO2 measurements and affecting alarm notifications.

    Product
    Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional accessory (sold separately) to the Merge Hemo Patient Data Module (PDM). The PDM is a major component of the Merge Hemo system.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0991-2017·2017-01-18

    ConforMIS iTotal PS Knee Implant Recalled for Software Measurement Error

    ConforMIS is recalling iTotal PS Knee Replacement Kits because the iView software displayed femoral cut measurements in the wrong unit.

    Product
    ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0878-2017·2016-12-28

    Merge OrthoCase software recall due to measurement errors

    Merge Healthcare is recalling OrthoCase software because measurements change after saving, potentially causing patient injury or delayed diagnosis.

    Product
    Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-2888-2016·2016-10-05

    Spiegelberg Brain Pressure Monitoring Probes Recalled for Measurement Errors

    Spiegelberg is recalling 22 Brain Pressure Monitoring System probes due to air chamber shrinkage that caused false high readings in the lower measuring range.

    Product
    Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Product Usage: lntracranial pressure measuring probes are used to measure intracranial pressure (intracranial pressure, ICP), so the pressure in the head.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2793-2016·2016-09-21

    Siemens Syngo Plaza PACS Recall for Measurement Display Suffix

    Siemens is recalling 101 Syngo Plaza PACS systems because a suffix on DICOM images may indicate that displayed measurements differ from actual values.

    Product
    Syngo Plaza picture archiving and communication system (PAC) (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2587-2016·2016-08-24

    Nidek Optical Biometer AL-Scan Recalled for Inaccurate Axial Length Measurements

    Nidek Inc. is recalling 17 Optical Biometer AL-Scan devices because they measured axial lengths as much shorter than actual values.

    Product
    OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature rad
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0794-2016·2016-02-17

    Merge Healthcare Recalls RadSuite Picture Archive System for Measurement Errors

    Merge Healthcare is recalling RadSuite picture archive systems because they may display incorrect Standardized Uptake Values (SUV). The recall covers 164 units distributed nationwide.

    Product
    RadSuite, a picture archive and communications system. Model Numbers Versions 5.30.0, 5.30.1, 5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E, 5.30.5 HF390E, 5.30.5 SB0368, 5.30.6, 5.30.6 HF0405E, 5.30.6 HF0406E, 5.30.7, 5.30.7 HF0429
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0564-2016·2016-01-06

    Biomet 3i Recalls Radiographic Transparencies Due to Undersized Images

    Biomet 3i is recalling 686 radiographic transparencies because the images are undersized, which may affect dental implant measurements.

    Product
    Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0177-2016·2015-11-04

    Philips Recalls Brilliance Big Bore CT Systems Due to X-ray Measurement Error

    Philips Medical Systems is recalling 268 Brilliance Big Bore CT systems worldwide due to X-ray measurement errors causing image artifacts.

    Product
    Brilliance Big Bore (Oncology & Radiology) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0176-2016·2015-11-04

    Philips Ingenuity Core 128 CT Systems Recalled for X-ray Measurement Error

    Philips Medical Systems is recalling 109 Ingenuity Core 128 CT systems due to X-ray measurement errors causing image artifacts.

    Product
    Ingenuity Core 128 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0175-2016·2015-11-04

    Philips Ingenuity Core CT Systems Recalled for X-ray Measurement Error

    Philips is recalling 36 Ingenuity Core CT systems worldwide due to an X-ray measurement error that causes Ring/Dot artifacts in images.

    Product
    Ingenuity Core Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0173-2016·2015-11-04

    Philips Recalls Brilliance 16-Slice CT Systems Due to X-ray Measurement Error

    Philips Medical Systems is recalling 323 Brilliance 16-Slice CT systems worldwide due to X-ray measurement errors causing Ring/Dot artifacts.

    Product
    Brilliance 16-Slice (Air) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0178-2016·2015-11-04

    Philips Recalls Ingenuity Flex CT Systems Due to X-ray Measurement Error

    Philips Medical Systems is recalling 67 Ingenuity Flex CT systems worldwide due to an X-ray measurement error that causes Ring/Dot artifacts in images.

    Product
    Ingenuity Flex Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2439-2015·2015-09-02

    PTW UNIDOS webline Dosimeters Recalled for Potential Radiation Over-Exposure

    PTW-Freiburg is recalling PTW UNIDOS webline dosimeters because measurement errors at high dose rates could display too-low doses, potentially leading to radiation over-exposure.

    Product
    PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics.
    Category
    Medical Device
    Distribution
    10 states