The Recall Desk

Hazard

Calibration Error recalls

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

What the numbers show

Total
152
Critical
0
Severe
8
Most recent
2026-07-22

Of the 152 calibration 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 8 (5%) 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 calibration 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.

76–100 of 152

  • SevereFDA (Devices)·Z-3047-2017·2017-08-30

    Solta Medical Recalls VASER Amplifiers Due to Burn Risk

    Solta Medical is recalling four VASER Amplifier units because a service depot repair may have caused inaccurate calibration, posing a burn risk to patients.

    Product
    VASER Amplifier, VASER 2.2 VASERlipo System, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy).
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-3048-2017·2017-08-30

    Solta Medical Recalls VASER PRO Amplifiers Due to Burn Risk

    Solta Medical is recalling seven VASER PRO Amplifiers because a service depot repair may have caused inaccurate calibration, posing a risk of patient burns.

    Product
    VASER PRO Amplifier, VASER 2.2 VASERlipo System stem, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy).
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2730-2017·2017-07-19

    Beckman Coulter Synchron AQUA CAL Level 1 Calibration Kits Recalled

    Beckman Coulter is recalling Synchron AQUA CAL Level 1 kits due to a sodium recovery shift that may affect system calibration.

    Product
    Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl, Urea N, Urea, Glucose Creatine, Ca, CO2, and P in UniCel DxC Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2159-2017·2017-05-31

    MesaLabs Conductivity Standard Solution Recalled for Specification Failure

    Mesa Laboratories is recalling 9,900 units of Conductivity/TDS Calibrator Solution because the product failed to meet specifications. The solution is used for calibrating hemodialysis equipment and does not contact patients.

    Product
    MesaLabs Conductivity Standard Solution, 14 mS/cm, 32 ounces (950 ml). Product No. : 02.0027, 020510 (carton of 6 of 02.0027). Polyethylene bottle Conductivity/TDS Calibrator solutions are a secondary standard solution used for the calibration of conductivity/TDS cells toget
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1216-2017·2017-02-22

    Siemens Enzyme 2 Calibrator Recalled for Positive Result Shifts

    Siemens Healthcare Diagnostics is recalling Enzyme 2 Calibrators because they may cause patient and QC results to shift up to 10% when used with the Dimension Vista System.

    Product
    The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate Aminotransferase (AST) methods on the Dimension Vista System. For prescription use only.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0070-2017·2016-10-19

    Medtronic O-arm O2 Surgical Imaging System Recalled for Calibration Errors

    Medtronic is recalling 14 O-arm O2 Surgical Imaging Systems because spatial calibration may be erroneous in navigated images, potentially affecting surgical accuracy.

    Product
    Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm Surgical Imaging System is a multi-dimensional surgical imaging platform that is designed for use in spine, orthopaedic, and trauma-related surgeries. It provid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2145-2016·2016-07-20

    Ortho VITROS AFP Reagent Pack Recall Due to Calibration Failure

    Ortho Clinical Diagnostics is recalling specific lots of VITROS AFP Reagent Packs because they may fail to calibrate, potentially affecting test results.

    Product
    VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: the VITROS Immunodiagnostic Products AFP Calibrators, Unique Device Identifier No.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2005-2016·2016-06-29

    Siemens Biograph mCT-X 4R PET/CT Scanners Recalled for Calibration Error

    Siemens is recalling 83 Biograph mCT-X 4R scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph mCT-X 4R, MATERIAL NUMBER 10248670 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
  • HighFDA (Devices)·Z-2017-2016·2016-06-29

    Siemens Biograph PET/CT Scanner Upgrade Recalled for Calibration Error

    Siemens Medical Solutions is recalling 2 Biograph TruePoint scanner upgrades because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581 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 inf
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2009-2016·2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling 46 Biograph 40 TruePoint PET/CT scanners due to a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

    Product
    BIOGRAPH 40 TruePoint w/TrueV, Material Number 10097304 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-2031-2016·2016-06-29

    Siemens Biograph mCT-S PET/CT Scanners Recalled for Calibration Error

    Siemens Medical Solutions is recalling 100 Biograph mCT-S PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph mCT-S(40) 4R, MATERIAL NUMBER 10248671 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-2010-2016·2016-06-29

    Siemens Biograph TruePoint CT/PET Scanner Upgrade Recalled for Calibration Error

    Siemens is recalling a Biograph TruePoint upgrade kit because using a non-Siemens phantom for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH 40-3R to 64-3R Upgrade, Material Number 10246390 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 informa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2006-2016·2016-06-29

    Siemens Biograph 16 TruePoint TV Recall for Calibration Error

    Siemens is recalling 36 Biograph 16 TruePoint TV scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph 16 TruePoint TV, Material Number 10249556 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-2020-2016·2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling nine Biograph mCT Flow 20-3R scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH mCT Flow 20-3R, MATERIAL NUMBER 10528956 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-2019-2016·2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling two Biograph PET/CT scanners due to a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

    Product
    BIOGRAPH SYS 64-3R to 64-4R, MATERIAL NUMBER 10246389 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-2015-2016·2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling 49 Biograph PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH 64-4R TruePoint w/TrueV, MATERIAL NUMBER 10097302 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 inform
    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-2018-2016·2016-06-29

    Siemens Biograph TruePoint PET/CT Scanner Recall for Calibration Error

    Siemens is recalling four Biograph TruePoint PET/CT scanners due to a potential for unexpected SUV values when non-Siemens phantoms are used for calibration.

    Product
    BIOGRAPH Sys 40-3R to 40-4R, MATERIAL NUMBER 10246388 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-2022-2016·2016-06-29

    Siemens Biograph TruePoint PET/CT Scanners Recalled for Calibration Error

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

    Product
    BIOGRAPH mCT Flow 40-3R, MATERIAL NUMBER 10529158 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-2013-2016·2016-06-29

    Siemens Biograph 64 PET/CT Scanner Recall for Calibration Error

    Siemens is recalling 15 Biograph 64 PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH 64 - 3 Ring, Material Number 08727450 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-2027-2016·2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling 13 Biograph mCT Flow Edge-4R scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH mCT Flow Edge-4R, MATERIAL NUMBER 10528955 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-2032-2016·2016-06-29

    Siemens Biograph mCT-S PET/CT Scanners Recalled for Calibration Error

    Siemens is recalling 51 Biograph mCT-S PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph mCT-S(64) 3R, MATERIAL NUMBER 10248669 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-2025-2016·2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling 25 Biograph mCT Flow 64-4R scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH mCT Flow 64-4R, MATERIAL NUMBER 10529161 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-2024-2016·2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling 12 Biograph mCT Flow 64-3R scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH mCT Flow 64-3R, MATERIAL NUMBER 10529160 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-2036-2016·2016-06-29

    Siemens Biograph TruePoint PET/CT Scanner Recall for Calibration Error

    Siemens is recalling two Biograph TruePoint PET/CT scanners due to a potential for unexpected SUV values when using non-Siemens phantoms for calibration.

    Product
    SYS IVK, Bio mCT-X 3R->4R Upgrade, MATERIAL NUMBER 10250745 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 infor
    Category
    Medical Device
    Distribution
    Distributed nationwide