The Recall Desk

Hazard

Data Inaccuracy recalls

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

What the numbers show

Total
12
Critical
0
Severe
0
Most recent
2020-07-08

Of the 12 data 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 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 data 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.

1–12 of 12

  • HighFDA (Devices)·Z-2479-2020·2020-07-08

    Preventice BodyGuardian Heart Remote Monitoring Kit Recalled for Data Accuracy Issues

    Preventice Services is recalling eight BodyGuardian Heart Remote Monitoring Kits because unvalidated software may cause inaccurate data collection, making patient reports unreliable for condition evaluation.

    Product
    BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors, either Models BC-1001-A or BC1001-D, and a cell phone, either Models BP1008 or BP10014, that is paired to both of the monitors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1381-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data during scanning.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA474
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1370-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA354
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1377-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA456
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1380-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data during scanning.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA466
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1368-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data during scanning.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 6MM(H) Reference Number: IEHA346
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1382-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H) Reference Number: IEHA553
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2014-2016·2016-06-29

    Siemens Biograph TruePoint PET/CT Scanners Recalled for Calibration Error

    Siemens is recalling 16 Biograph TruePoint PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH 64-3R TruePoint, MATERIAL NUMBER 10097301 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1970-2015·2015-07-08

    Tecan Infinite 200 PRO Microplate Reader Recalled for Firmware Bug

    Tecan US, Inc. is recalling 868 Infinite 200 PRO microplate readers because a firmware bug causes incorrect luminescence values to be displayed.

    Product
    Infinite 200 PRO in vitro diagnostic. Product Usage: The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of todays microplate applications and research and is robotic c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1359-2015·2015-04-08

    Philips CT Systems Recalled for Inverted Scan Position Software Defect

    Philips is recalling 424 CT systems worldwide because a software defect inverts the sign of the longitudinal position for some scans.

    Product
    Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128 & Ingenuity CT), Philips Medical Systems, Cleveland, OH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1163-2013·2013-05-01

    Varian RPM Respiratory Gating System Recall for Waveform Anomaly

    Varian is recalling RPM Respiratory Gating System v1.7.5 units because they may produce inverted respiratory waveforms during specific sessions.

    Product
    Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model Number: HS2 Product Usage: The RPM device is to be used to characterize the patients respiratory motion information to synchronize their operation with the respiratory motion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1831-2012·2012-06-27

    Spacelabs Healthcare Recalls Pathfinder SL Holter Analyzer Software

    Spacelabs Healthcare is recalling Pathfinder SL software due to crashes and incorrect QTc values. The software is used to analyze Holter monitor data.

    Product
    The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. Product Usage: The Holter Analyzer analyzes information collected from ambulatory electrocardiogram recorders worn by patients and used t
    Category
    Medical Device
    Distribution
    Distributed nationwide