Brainlab AG: 39 FDA recall reports
Every medical device recall the FDA has published for Brainlab AG. The fault, and how the agency graded it.
39Reports
2Class I
4Ongoing
2025-03-26Most recent
2 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Z-1392-2025 · Class II · reported 2025-03-26 · Ongoing
- Why it was recalled
- Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification.
- Product
- Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- N/A
Cirq Arm System 2.0
Z-1292-2023 · Class II · reported 2023-04-05 · Ongoing
- Why it was recalled
- Risk of mechanical instability due to potential manufacturing error of the device
- Product
- Cirq Arm System 2.0
- Where it went
- Texas
- How much
- 1 unit
Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 209
Z-1259-2023 · Class II · reported 2023-03-22 · Ongoing
- Why it was recalled
- Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
- Product
- Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
- Where it went
- US Nationwide distribution in the states of AZ, AR, CA, CO, FL, GA. IL, IN, KY, LA, MS, MO, NJ, NY, NC, ND, OK, OR, PA, TN, TX, VA, and WA. There was no government/military distribution.
- How much
- 56 systems in the U.S.
ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Po
Z-0733-2022 · Class II · reported 2022-03-16 · Ongoing
- Why it was recalled
- The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
- 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.
- Where it went
- Distribution was made to AZ, AR, CA, CO, FL, GA, IN, KY, MD, MS, MO, NJ, NY, NC, OK, OR, PA, TX, VA, and WA. There was no government or military distribution. Foreign distribution was made to Australia, Austria, Bahrain, Belgium, China, Denmark, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, New Zealand, Poland, Singapore, Slovakia, South Korea, Spain, Thailand, Turkey, United Kingdom, and United Arab Emirates.
- How much
- 205 systems
ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: int
Z-1846-2021 · Class II · reported 2021-06-16 · Terminated
- Why it was recalled
- Display of potential patient movement might be delayed to the user for high dose treatments.
- Product
- ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position, and to provide a beam hold signal in case of a deviations in order to treat lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
- Where it went
- US Nationwide distribution in the states of AZ, AR, CA, FL, IN, NJ, NY, NC, OR, PA, and TX. There was no government/military distribution.
- How much
- 22 systems in the U.S.
ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
Z-1185-2021 · Class II · reported 2021-03-17 · Terminated
- Why it was recalled
- In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current patient position is within predefined tolerances and may allow the user to proceed to treatment despite potentially exceeding shift values.
- Product
- ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
- Where it went
- USA: (CA, NJ, AZ, AR, NY, IN, OR, NC), Australia, Austria, Belgium, Denmark, France, Germany, Hong Kong, Italy, Slovakia, Spain, Thailand, Turkey, United Kingdom, United Arab Emirates.
- How much
- 73 ExacTrac Dynamic systems (versions 1.0.0, 1.0.1, 1.0.2) have been manufactured and distributed
Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.
Z-0056-2021 · Class II · reported 2020-10-14 · Terminated
- Why it was recalled
- Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.
- Product
- Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended to be an intra-operative image guided localization system to enable minimally invasive surgery.
- Where it went
- Worldwide distribution - US Nationwide distribution including in the states of Illinois, Massachusetts, Texas, California, Idaho, Missouri, Oregon, Connecticut and the countries of Australia, Austria, Belgium, Brazil, Canada, China, Curacao, Czech Republic, Egypt, Finland, France, Germany, Switzerland, Netherlands, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kuwait, Malaysia, Myanmar, Norway, Pakistan, Romania, Slovakia, South Africa, Spain, Sweden, Thailand, Turkey and United Kingdom.
- How much
- 271 units
Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000-01C) of the CIRQ Arm System (
Z-2925-2020 · Class II · reported 2020-09-09 · Terminated
- Why it was recalled
- Holding force of the Positioning Arm can be reduced by prolonged non-use.
- Product
- Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000-01C) of the CIRQ Arm System (56000 and 56000A)
- Where it went
- USA: DC, OH, IL OUS: Bulgaria; France; Germany; United Kingdom
- How much
- 21 arms
BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 0405648100665
Z-2793-2020 · Class II · reported 2020-08-19 · Terminated
- Why it was recalled
- Incorrect manufacturer calibration
- Product
- BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655
- Where it went
- USA: CA, TX, RI OUS: Armenia; Australia; Brazil; Bulgaria; Canada; Finland; France; Germany; Hong Kong; India; Israel; Italy; Japan; Mongolia; Morocco; Spain
- How much
- 9 unit
BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curv
Z-2792-2020 · Class II · reported 2020-08-19 · Terminated
- Why it was recalled
- Incorrect manufacturer calibration
- Product
- BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011
- Where it went
- USA: CA, TX, RI OUS: Armenia; Australia; Brazil; Bulgaria; Canada; Finland; France; Germany; Hong Kong; India; Israel; Italy; Japan; Mongolia; Morocco; Spain
- How much
- 18 units
Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY 25100-10
Z-0176-2020 · Class II · reported 2019-10-30 · Terminated
- Why it was recalled
- The Brainlab Patient Data Manager software (PDM) in combination with the Brainlab iPlan CMF/Cranial/ENT/Spine software 2.1.1, 2.2.0, 2.2.1, 2.3.0, 2.3.1, 2.4.0, 2.5.0, 2.5.1 (if used in combination with iPlan CMF/Cranial/ENT/Spine 3.0.5, 3.0.6) that may lead to shifts applied to segmentation objects in iPlan being not reflected when exported into DICOM under specific circumstances.
- Product
- Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY 25100-10 - PATIENT DATA MANAGER 2.2.0 LICENSE ONLY 25100-11 - PATIENT DATA MANAGER 2.2.1 LICENSE ONLY 25100-12 - PATIENT DATA MANAGER 2.3 INSTALLER 25100-12A - PATIENT DATA MANAGER 2.3.1 INSTALLER 25100-13 - PATIENT DATA MANAGER 2.3 LICENSE 25100-12B - PATIENT DATA MANAGER 2.4.0 INSTALLER 25100-13A - PATIENT DATA MANAGER 2.4 LICENSE 25100-12C - PATIENT DATA MANAGER 2.5.0 INSTALLER 25100-12D - PATIENT DATA MANAGER 2.5.1 INSTALLER 25100-13B - PATIENT DATA MANAGER 2.5 LICENSE used in combination with iPlan CMF/Cranial/ENT/Spine 3.0.5, 3.0.6. Product Usage: Patient Data Manager is intended to load patient data from and export patient data to connected network locations (like file shares and PACS) and removable media. Furthermore, the software is intended to start other applications (like Brainlab planning and navigation applications) and to route applications and connected video sources to displays attached to the system that are running Patient Data Manager. The software is also intended to connect two Brainlab systems to each other via network.
- Where it went
- worldwide
- How much
- 1230 units
RT Elements Software revisions of the RT Elements applications have a specific software version number. Spec
Z-1205-2019 · Class II · reported 2019-05-01 · Terminated
- Why it was recalled
- There is a potential for an incorrect dose distribution calculation by Brainlab RT Elements software (for affected versions) under specific circumstances when using the Pencil Beam algorithm on the GPU (graphics card), as is the default system setting.
- Product
- RT Elements Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements applications/versions are affected: - Cranial SRS 1.0.0 and 1.5.0 - Spine SRS 1.0.0 and 1.5.0 - Multiple Brain Mets SRS 1.5.0 - RT QA 1.0.0 and 1.5.0 Product Usage: The RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck and extracranial lesions.
- Where it went
- Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IN, KY, LA, MA, MD, MS, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, & WV. Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, El Salvador, Finland, France, Germany, Hong Kong, Iran, Ireland, Israel, Italy, Japan, Jordan, Lebanon, Martinique, Mexico, Monaco, Morocco, Netherlands, Poland, Portugal, Russian Fed., South Africa, South Korea, Spain, Switzerland, Taiwan, Tunisia, United Arab Emirates, and United Kingdom.
- How much
- US - 164 units; Outside the US - 333
Class I
Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 )
Z-1082-2019 · Class I · reported 2019-04-24 · Terminated
- Why it was recalled
- In certain occurrences, the affected navigation software application might unexpectedly display a navigated instrument in an axial, coronal/sagittal (ACS) view representation with fixed planes in the image reconstruction (the not-updated ACS view ), instead of displaying the desirable view representation Inline View , which is commonly used for navigating invasive instruments at the spine. This could lead the surgeon to be unable to determine the position of the navigated instrument. This might occur after a crash restore or after changing between different navigation workflows during the same patient treatment.
- Product
- Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Use The Spine & Trauma Navigation System is intended as an intraoperative image-guided localization system to enable minimally invasive surgery.
- Where it went
- Worldwide Distribution: US (Nationwide) and countries of: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Ecuador, France, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Kazakhstan, Malaysia, New Zealand, Philippines, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand and United Kingdom.
- How much
- 148 units
ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within
Z-1006-2018 · Class II · reported 2018-03-21 · Terminated
- Why it was recalled
- The usage of workflows that deviate from the recommended specifications in the User manual for ExacTrac Patient Positioning System (versions 6.0, 6.1, 6.2, 6.5) with Auxiliary Device Interface (ADI) and Varian Clinac or Varian TrueBeam, which may result in misinterpretation of beam authorization via ADI.
- Product
- ExacTrac versions 6.5 through 6.5 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 treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.
- Where it went
- worldwide
- How much
- 587 systems
AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used for X-ray co
Z-0509-2018 · Class II · reported 2018-02-14 · Terminated
- Why it was recalled
- Risk of unintended motion while the AIRO system is in transport mode.
- Product
- AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs. (182 kg).
- Where it went
- Worldwide Distribution - US Nationwide in the U.S. States: of AK, AZ, CA, CO, FL, GA, IL, KY, LA, MD, MA, MI, MN, MT, MO, NJ, NY, NC, OH, PA, RI, TN, TX, UT, VA, WA, and WV; and the countries of Argentina, Australia, Austria, Belgium, Canada, Egypt, France, Germany, India, Italy, Japan, Kazakhstan, Lithuania, Netherlands, Saudi Arabia, Spain, Switzerland, United Arab Emirates, and Uzbekistan.
- How much
- 102
Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeih
Z-0320-2018 · Class II · reported 2018-01-17 · Terminated
- Why it was recalled
- Due to a human error at a supplier, an unknown number of devices within one specific production lot of Brainlab DrapeLink Adapters (Left/Right) were not manufactured according to defined specifications.
- Product
- Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left
- Where it went
- Distributed in the US to Kansas. Distributed internationally to Australia, Finland, France, Germany, Hong Kong, Ireland, Japan, Netherlands, Norway, Sweden, Switzerland, Taiwan, Turkey, United Kingdom.
- How much
- 80 devices total
BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXAC
Z-0172-2018 · Class II · reported 2017-12-06 · Terminated
- Why it was recalled
- Brainlab has internally detected that under specific conditions ExacTrac Vero may not correctly account for this ring angle correction during the calculation of the corresponding couch shift. This may result in the treatment couch not moving to the exact planned position resulting in a deviation between the planned and the treatment target position. This deviation may not be clearly visible to the user if no verification image of the patient position is acquired after this couch shift has been performed.
- 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 Radiation Therapy Linear Accelerator System manufactured by Mitsubishi Heavy Industries, Ltd. ExacTrac Vero uses the images received from the MHI-TM2000 linear accelerator for analyzing the current patient position and calculating - when applicable - a necessary correction shift. The correction shift is then exported to the MHI-TM2000 linear accelerator. The ExacTrac Vero system uses stereoscopic X-ray or Cone Beam CT registration and optical tracking of infrared reflective markers in order to localize and correct the patient position before and during treatment. Optionally ExacTrac Vero provides position data for the pan/tilt motion of the MHI-TM2000 gantry head to the MHITM2000 controller for continuous alignment of the beam orientation with a moving target. The position data is based on target detection via X-ray imaging and IR tracking of external surrogate markers.
- Where it went
- Worldwide Distribution - US Distribution and to the countries of : Belgium, Canada, France, Germany, Italy, Japan and S. Korea
- How much
- 28 units
Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrumen
Z-0959-2017 · Class II · reported 2017-01-18 · Terminated
- Why it was recalled
- Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter Base with specific serial numbers might contain parts made from incorrect material and therefore not be suitable for reprocessing
- Product
- Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic
- Where it went
- US Consignees located in the following states: New York, Wisconsin, Oklahoma and District of Columbia.***Foreign Conisgnees located in the following countries: Australia; Belarus; Germany; India; Japan; Malaysia; Singapore; Switzerland; United Arab Emirates and United Kingdom.
- How much
- 29 units
ExacTrac Vero is a Patient Positioning System for Radiation therapy.
Z-1929-2016 · Class II · reported 2016-06-15 · Terminated
- Why it was recalled
- Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5
- Product
- ExacTrac Vero is a Patient Positioning System for Radiation therapy.
- Where it went
- Distributed in the states of Florida, New York, Texas and Ohio, and in the countries of Belgium, France, Germany, Italy, Japan and South Korea.
- How much
- 27 Systems
Class I
Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. T
Z-0598-2016 · Class I · reported 2016-01-27 · Terminated
- Why it was recalled
- Software Error: The effect of setup on overall navigation accuracy could potentially intensify small inaccuracies arising from individual steps of a complex navigation procedure that may cause an inaccurate display of instruments by the navigation system compared to the actual patient anatomy.
- Product
- Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.
- Where it went
- Worldwide Distribution: US (Nationwide) including Puerto Rico; and countries of: Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Latvia, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, and Vietnam.
- How much
- 2528 units / 2119 consignees
RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer pla
Z-0648-2016 · Class II · reported 2016-01-20 · Terminated
- Why it was recalled
- Large objects with fine resolution are potentially displayed cropped when imported into Adaptive Hybrid Surgery Analysis version 1.0.0
- Product
- RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms
- Where it went
- Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Mexico, Portugal, South Korea, Spain, Switzerland, Turkey and the United Kingdom.
- How much
- 48 systems
RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer pla
Z-0647-2016 · Class II · reported 2016-01-20 · Terminated
- Why it was recalled
- Large objects with fine resolution are potentially displayed cropped when imported into Brainlab Brain Metastases 1.0.0.
- Product
- RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms
- Where it went
- Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Mexico, Portugal, South Korea, Spain, Switzerland, Turkey and the United Kingdom.
- How much
- 20 systems
BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2
Z-0282-2016 · Class II · reported 2015-11-25 · Terminated
- Why it was recalled
- Instances of data sets not being accurately registered to the patient anatomy were observed.
- Product
- BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D versions 2.0 and 2.1 An intraoperative image-guided localization system to enable minimally invasive surgery.
- Where it went
- Distributed in the US and Australia.
- How much
- 12 systems total (10 in U.S., 2 in Australia)
Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager
Z-0218-2016 · Class II · reported 2015-11-11 · Terminated
- Why it was recalled
- Potentially incorrectly displayed objects when actively deselecting a fused reference dataset.
- Product
- Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, basic measurements and 3D visualization (reconstructions and volume rendering). Features for navigation planning include multi-modality image fusion as well as object and trajectory creation. It is not intended for primary image diagnosis or the review of mammographic images.
- Where it went
- Worldwide Distribution - US Nationwide and the countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Cambodia, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Japan, Lithuania, Malaysia, Malta, Mexico, Moldova, Morocco, Myanmar, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom and Vietnam.
- How much
- 897
Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in conjunction with a st
Z-2795-2015 · Class II · reported 2015-09-30 · Terminated
- Why it was recalled
- Disposable Reflective Marker Spheres (DRMS) for Brainlab Image Guided Surgery (IGS) Systems: DRMS spheres may separate at the mid-point where the two halves of the sphere are sealed together.
- Product
- Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in conjunction with a stereotaxic instrument consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system. They are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field. Radiology.
- Where it went
- Worldwide Distribution: US (nationwide) including states of: TX, CA, TN, NY, LA, IL, MA, PA, OH, AZ, ID, CT, MI, and KY; and countries of: Algeria, Argentina, Australia, Bahrain, Belarus, Bolivia, Brazil, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Libya, Lithuania, Malaysia, Malta, Mexico, Moldova, Morocco, Myanmar, Netherlands, Philippines, Poland, Portugal, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, , Venezuela, and Vietnam.
- How much
- For 28 US consignees, 9,900 Disposable reflective marker spheres ***For 451 non-US consignees, 359,280 Disposable reflective marker spheres
ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to be used to place patients at an
Z-2440-2015 · Class II · reported 2015-09-02 · Terminated
- Why it was recalled
- ExacTrac 6.0 Patient Positioning System: Display of potentially incorrect Digitally Reconstructed Radiograph (DRR) for x-ray correction and verification.
- 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.
- Where it went
- Worldwide Distribution - USA including the states of AL, AZ, AK, CA CO, CT, FL, GA, ID, IL IN, KY, LA, MD, MA, MI, MN, NE, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, and WI; and, the countries of Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Finland, France, Germany, Hong Kong, India, Israel, Italy, Japan, Netherlands, Panama, Qatar, Russia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.
- How much
- 361 systems
ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a
Z-1582-2015 · Class II · reported 2015-05-13 · Terminated
- Why it was recalled
- ExacTrac 6.x Patient Positioning System: Potentially incorrect patient positioning when using the ExacTrac Cone Beam CT (CBCT) with a CBCT acquired at a couch angle other than 0.0 degrees.
- 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.
- Where it went
- *** US: Nationwide; *** FOREIGN: Austria, China, Denmark, France, Germany, Hong Kong, Japan, Netherlands, Qatar, Russian Federation, South Korea, Switzerland
- How much
- 25 systems (US only); 53 systems (Foreign)
ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radioth
Z-1316-2015 · Class II · reported 2015-04-01 · Terminated
- Why it was recalled
- The ExacTrac 6.x Patient Positioning System may incorrectly position the patient when using the ExacTrac Cone Beam CT (CBCT) with a TrueBeam-specific optional subvolume-CBCT.
- Product
- ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..
- Where it went
- Worldwide Distribution - USA and to the countries of : Australia, Austria, Canada Denmark, France, Germany, Hong Kong, Japan, Russia, Singapore, South Korea and United Kingdom.
- How much
- 24 systems (US); 36 systems (Foreign)
The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided
Z-1215-2015 · Class II · reported 2015-03-04 · Terminated
- Why it was recalled
- The recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level.
- 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)
- Where it went
- Worldwide Distribution - US: Nationwide (AZ, CA, ID, IL, MD, MI, MN, OH, OK, OR, TN, WA, WI, WV); Australia, Austria, Bahrain, Belgium, Germany, Hong Kong, India, Italy, Japan, Malaysia, Russian Federation, Saudi Arabia, South Korea, Spain, Switzerland, Thailand, United Arab Emirates, United Kingdom
- How much
- 114 offset cup impactors
iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, compute
Z-0957-2015 · Class II · reported 2015-01-21 · Terminated
- Why it was recalled
- iPlan RT Radiation Treatment Planning Software: Potentially 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.
- Where it went
- Worldwide Distribution - USA including Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin, Wyoming and Internationally to Algeria, Angola, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, Norway, Oman, Panama, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, and Venezuela.
- How much
- 1412 systems total
Showing the 30 most recent of 39. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
← All device recalls