The Recall Desk

Hazard

Positioning Error recalls

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

What the numbers show

Total
18
Critical
0
Severe
2
Most recent
2026-03-04

Of the 18 positioning 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 2 (11%) 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 positioning 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.

1–18 of 18

  • SevereFDA (Devices)·Z-1429-2026·2026-03-04

    Hitachi Proton Beam Therapy System Recall Over Positioning Software Issue

    Hitachi is recalling one Proton Beam Therapy System due to a software anomaly in the patient positioning system that may cause positional discrepancy during treatment.

    Product
    Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1092-2026·2026-01-21

    Patient positioning systems recalled over stereotactic radiosurgery tolerance errors

    C-RAD Positioning is recalling 189 Catalyst and Catalyst+ systems because the system may indicate a patient as correctly positioned at the isocenter when it is outside tolerance.

    Product
    Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-0002 Software Version: cSRS module in combination with cMotion module Product Description: GMDN: 40893 Patient positioning device, diagnostic imaging/radiotherapy, laser Component
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1860-2025·2025-06-04

    DORO Easy-Connect Navigation Adaptor compatibility issue recall

    Pro-Med Instruments is recalling the DORO Easy-Connect Navigation Adaptor due to potential compatibility problems that could affect positioning accuracy and navigation system function. The company distributed 217 units worldwide.

    Product
    DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1758-2024·2024-05-15

    Spinal Fusion Device Recall: Setscrew Insertion and Tightening Issues

    SPINEART's PERLA TL 25D spinal fusion screws are being recalled due to difficulties with setscrew insertion inside the screw head. The setscrew may not be properly tightened or may be positioned incorrectly, potentially affecting spinal stability.

    Product
    PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S TLF-DS 45 45-S TLF-DS 55 30-S TLF-DS 55 35-S TLF-DS 55 40-S TLF-DS 55 45-S TLF-DS 65 35-S TLF-DS 65 40-S TLF-DS 65 45-S TLF-DS 65 50-S The PERLA¿ TL system is intended to provide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0127-2024·2023-11-01

    TruDi Navigation System position discrepancy during ENT surgery

    A surgical navigation system used in ENT procedures may display incorrect curette tip positions, potentially causing delayed surgery, cerebrospinal fluid leaks, vision loss, or skull damage. The recall affects 141 units across 30 US states.

    Product
    TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-0994-2022·2022-05-04

    Radiation therapy software update displays incorrect laser positioning

    Siemens syngo.via RT imaging software upgraded to VB60 automatically modifies laser configuration, potentially displaying incorrect laser offset coordinates during radiation therapy patient marking.

    Product
    syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0733-2022·2022-03-16

    ExacTrac Dynamic Software Yaw Angle Error May Affect Radiotherapy Positioning

    ExacTrac Dynamic radiotherapy positioning software (versions 1.0.0–1.0.3) may calculate incorrect yaw angle for patient positioning with Varian linear accelerators, potentially affecting cone-beam CT imaging setup accuracy during radiotherapy.

    Product
    ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST.
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-2029-2021·2021-07-14

    ARTIS Angiography System Software Error Causes C-Arm Positioning Deviation

    A software error in ARTIS angiography systems can cause the C-arm to deviate from intended position by up to 22 cm during imaging procedures. Affected units require identification by serial number.

    Product
    ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1467-2020·2020-03-18

    RayStation 9A Software Recall for Pitch and Roll Correction Errors

    RaySearch Laboratories is recalling one RayStation/RayPlan 9A system in Tennessee due to potential errors in position propagation when pitch or roll corrections are applied.

    Product
    RayStation/RayPlan 9A, Build Number 9.0.0.113, stand-alone software treatment planning system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2230-2019·2019-08-21

    Elekta iGUIDE System Recalled for Potential Position Monitoring Error

    Elekta is recalling 374 iGUIDE Systems because they may incorrectly monitor 3D position. The recall covers devices distributed nationwide and worldwide.

    Product
    iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2537-2018·2018-08-01

    Forte Automation Patient Positioning System Recalled for Communication Failures

    Forte Automation Systems is recalling 13 patient positioning systems in California due to periodic communication failures with the accuracy filter that may not be indicated to the operator.

    Product
    Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10 Product Usage: The patient positioning system is a SCARA designed robotic arm designed to position a patient for medical procedures prescribed by oncologists and others that require a high
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0638-2018·2018-02-28

    ROSA Brain 3.0 Stereotaxic Instrument Recalled for Positioning Errors

    Zimmer Biomet is recalling 16 ROSA Brain 3.0 Stereotaxic instruments because the robot arm may move to the wrong position during surgery.

    Product
    ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0172-2018·2017-12-06

    Brainlab ExacTrac Vero Radiation Therapy System Recall for Positioning Error

    Brainlab is recalling ExacTrac Vero systems because a software error may cause the treatment couch to miss the planned position, potentially affecting radiation therapy accuracy.

    Product
    BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46218 EXACTRAC VERO SW UPDATE 3.5.3 TO 3.5.4 The ExacTrac Vero system is intended to be used in conjunction with the MHI-TM2000 Rad
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2691-2016·2016-09-07

    Elekta Recalls HexaPOD evo RT Systems for Positioning Errors

    Elekta is recalling 13 HexaPOD evo RT Systems because the treatment couch may not move fully to the correct 3D position, potentially leading to unrecognized positioning errors during radiotherapy.

    Product
    HexaPOD evo RT System Product Usage: The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1705-2016·2016-06-01

    Elekta iGUIDE System Software Recall for Radiotherapy Positioning Errors

    Elekta, Inc. is recalling 20 iGUIDE Systems due to a software issue that may allow pre-treatment imaging to be performed before the HexaPOD is in the correct position.

    Product
    iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1238-2015·2015-03-25

    Elekta Precise Treatment Table Recalled for Positioning Error Risk

    Elekta is recalling Precise Treatment Tables because incorrect sensor installation during maintenance can cause undetected positioning errors, potentially leading to clinical mistreatment.

    Product
    Elekta Precise Treatment Table
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1271-2014·2014-04-02

    Mevion S250 Proton Radiation Therapy System Recalled for Positioning Error

    Mevion Medical Systems is recalling the S250 Proton Radiation Therapy System because a geometric positioning error can occur after rotational corrections are applied to treatment fields.

    Product
    MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1155-2013·2013-05-01

    Accuray RoboCouch Patient Positioning System Recalled for Defective Gearboxes

    Accuray Incorporated is recalling 16 RoboCouch Patient Positioning Systems because A5 gearboxes responsible for pitch and roll motions may be defective.

    Product
    RoboCouch Patient Positioning System Product Usage: is intended for use in the support and positioning of a patient during radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required.
    Category
    Medical Device
    Distribution
    Distributed nationwide