The Recall Desk

Manufacturer

Brainlab AG

39 recalls in our database name Brainlab AG as the manufacturing or recalling firm.

What the numbers show

Total
39
Critical
0
Severe
3
Most recent
2025-03-26

Of the 39 recalls from Brainlab AG we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (8%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–39 of 39

  • HighFDA (Devices)·Z-2440-2015·2015-09-02

    Brainlab ExacTrac 6.0 Patient Positioning System Recalled for Display Error

    Brainlab AG is recalling ExacTrac 6.0.x software due to a potential display error in Digitally Reconstructed Radiographs used for x-ray correction.

    Product
    ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to be 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
    32 states
  • 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-1215-2015·2015-03-04

    Brainlab Offset Cup Impactor Universal Recall Due to Sterilization Failure

    Brainlab AG is recalling 114 Offset Cup Impactor Universal units because their sterilization parameters are ineffective. The recall covers units distributed worldwide prior to January 13, 2015.

    Product
    The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided localization system to enable minimally invasive orthopedic surgery. (a stereotaxic instrument)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-2213-2014·2014-08-20

    Brainlab Navigation Spine & Trauma 3D Software Recalled for Registration Error

    Brainlab AG is recalling 17 Navigation Spine & Trauma 3D software systems worldwide due to a defect in automatic CT image registration.

    Product
    Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoper
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2146-2014·2014-08-13

    Brainlab ExacTrac Software Recall for Potential Radiation Misalignment

    Brainlab AG is recalling ExacTrac v6.0.4 software because it may move patients to the wrong position during radiation treatment, potentially delivering the dose to an unintended target.

    Product
    ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treat
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2134-2014·2014-08-06

    Brainlab Patient Data Manager 2.0 Software Recall for Image Display Defects

    Brainlab AG is recalling Patient Data Manager 2.0 software due to defects in transferring and displaying non-square pixel medical images.

    Product
    Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the display of medical images. Model numbers 25100-05 and 25100-06. The software can transfer images to and from picture archiving and communicatio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1707-2014·2014-06-11

    Brainlab ExacTrac 5.5 Image Processing System Recalled for Plan Blending Error

    Brainlab AG is recalling ExacTrac 5.5 image processing systems because a specific workflow may generate unintended blends of separate patient treatment plans.

    Product
    ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1513-2014·2014-05-07

    Brainlab ExacTrac 6.0 Radiation Positioning System Recalled for Targeting Error

    Brainlab AG is recalling ExacTrac 6.0 systems because they may position patients to unintended radiation targets, potentially delivering dose to the wrong location.

    Product
    ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49927B ET UPGRA
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1469-2014·2014-04-23

    Brainlab Spine & Trauma 3D 2.0 Navigation Software Recalled for Registration Defect

    Brainlab AG is recalling 133 units of Spine & Trauma 3D 2.0 Navigation Software due to a defect in the fluoro match registration function.

    Product
    Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0967-2014·2014-02-19

    Brainlab VectorVision Spine Instrument Star Unit ML Recall

    Brainlab is recalling 25 VectorVision Spine Instrument Star Unit ML devices because pins may be made of incorrect material, posing a risk of corrosion and particle release during surgery.

    Product
    BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative image data that
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2083-2013·2013-09-04

    Brainlab Frameless SRS QA Target Pointer Cap Recall

    Brainlab AG is recalling 6 units of the Frameless SRS QA Target Pointer because the pointer cap may become loose under moderate force.

    Product
    BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or radiotherapy procedures. The Frameless Radiosurgery Components are a device u
    Category
    Medical Device
    Distribution
    1 state