The Recall Desk

Hazard

Incorrect Positioning recalls

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

What the numbers show

Total
16
Critical
0
Severe
1
Most recent
2025-06-04

Of the 16 incorrect positioning recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (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 incorrect positioning 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.

1–16 of 16

  • ModerateFDA (Devices)·Z-1858-2025·2025-06-04

    Catalyst+ Patient Positioning Software May Fail to Apply Rotation Correctly

    C-RAD POSITIONING AB has recalled Catalyst+ and related patient positioning devices due to a software issue where field rotation may not be applied correctly during scanning.

    Product
    Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (SP001-0027), Catalyst X4 (SP002-0035), Catalyst+ (SP003-0001), Catalyst+ HD (SP003-0002), Catalyst+ PT (SP003-0008), Cataly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0319-2024·2023-11-22

    CT Scanner Software Bug May Cause Gantry to Move to Wrong Position

    Philips Spectral CT on Rails software version 5.1.0 may fail to move the needle position to the desired location during scans. This could cause the gantry to move unexpectedly and potentially collide with the user or needle.

    Product
    Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1185-2021·2021-03-17

    Brainlab ExacTrac Dynamic Radiation Therapy System Software Recall

    Brainlab AG is recalling ExacTrac Dynamic radiation therapy systems due to a software error that may allow treatment despite exceeding position tolerances.

    Product
    ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1892-2019·2019-07-03

    Hitachi PROBEAT-V Proton Therapy System Software Recall

    Hitachi is recalling three PROBEAT-V proton therapy systems due to a potential software error that could result in incorrect target positioning during treatment.

    Product
    PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0776-2019·2019-02-13

    GE Healthcare Recalls Revolution CT Systems with SmartStep Option

    GE Healthcare is recalling 131 Revolution CT systems with the SmartStep Option because the displayed Z location may not match the actual table position, potentially causing scans at incorrect locations.

    Product
    Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2535-2018·2018-08-01

    Elekta Recalls HexaPOD evo RT Couch Top for Positioning Errors

    Elekta, Inc. is recalling 725 HexaPOD evo RT Couch Top devices because they may tilt incorrectly after specific workflows, leading to improper patient positioning during radiation therapy.

    Product
    HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of the HexaPOD evo RT system. Product Usage: To support and aid in positioning a patient during radiation therapy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2667-2016·2016-08-31

    Vision RT AlignRT Plus System Recalled for Unintended Couch Parameter Changes

    Vision RT Ltd is recalling 47 AlignRT Plus systems because unintended changes to couch rotation parameters were discovered during patient set-up. No patient harm was reported.

    Product
    AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2535-2016·2016-08-24

    Straumann Bone Level Implant Recalled for Misalignment with Transfer Piece

    Straumann Manufacturing, Inc. is recalling 33 Bone Level Implants due to misalignment with the Loxim transfer piece markings, which may result in incorrect implant positioning.

    Product
    Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Number: 021.4512
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2534-2016·2016-08-24

    Straumann Bone Level Implant Recalled for Misalignment with Transfer Piece

    Straumann Manufacturing is recalling 70 Bone Level Implants because misalignment with the Loxim transfer piece may result in incorrect implant positioning.

    Product
    Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1582-2015·2015-05-13

    Brainlab ExacTrac 6.x Software Recalled for Potential Positioning Errors

    Brainlab AG is recalling ExacTrac 6.x software due to potential patient positioning errors when using CBCT at non-zero couch angles.

    Product
    ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1316-2015·2015-04-01

    Brainlab ExacTrac 6.x Patient Positioning Systems Recalled for Positioning Errors

    Brainlab is recalling ExacTrac 6.x systems because they may incorrectly position patients during radiosurgery or radiotherapy when using specific CBCT software.

    Product
    ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0956-2015·2015-01-21

    Brainlab iPlan RT Dose Software Recalled for Potential Positioning Errors

    Brainlab AG is recalling iPlan RT Dose software because it may produce incorrect patient positioning when using multiple CT image data sets.

    Product
    iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0957-2015·2015-01-21

    Brainlab iPlan RT Software Recalled for Potential Incorrect Patient Positioning

    Brainlab AG is recalling iPlan RT radiation treatment planning software due to a risk of incorrect patient positioning when using multiple localized CT image data sets.

    Product
    iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-2277-2013·2013-10-02

    Elekta Recalls Monaco RTP System Radiation Therapy Treatment Planning System

    Elekta, Inc. is recalling 72 units of the Monaco RTP System Radiation Therapy Treatment Planning System because patients must be positioned as indicated by the treatment plan.

    Product
    Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning.
    Category
    Medical Device
    Distribution
    28 states