Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
3 linked reportsInjury 2Malfunction 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-02 | 0 | 1 |
| 2019-03 | 0 | 2.67 |
| 2019-04 | 0 | 2.33 |
| 2019-05 | 0 | 1.25 |
| 2019-07 | 0 | 1 |
| 2019-08 | 0 | 1.2 |
| 2019-09 | 0 | 4 |
| 2019-10 | 0 | 3 |
| 2019-11 | 0 | 1.33 |
| 2019-12 | 0 | 1.33 |
| 2020-01 | 0 | 3.6 |
| 2020-02 | 0 | 1.33 |
| 2020-03 | 0 | 1.83 |
| 2020-04 | 0 | 2.67 |
| 2020-05 | 0 | 4.2 |
| 2020-06 | 0 | 2.6 |
| 2020-07 | 0 | 1 |
| 2020-08 | 1 | 3.4 |
| 2020-10 | 0 | 4.75 |
| 2020-11 | 0 | 2.4 |
| 2020-12 | 0 | 3 |
| 2021-01 | 0 | 1.33 |
| 2021-02 | 0 | 1.67 |
| 2021-03 | 0 | 1.8 |
| 2021-04 | 0 | 1.8 |
| 2021-05 | 0 | 1.33 |
| 2021-06 | 0 | 2 |
| 2021-07 | 0 | 3.4 |
| 2021-08 | 0 | 2 |
| 2021-09 | 0 | 2 |
| 2021-10 | 0 | 1.17 |
| 2021-11 | 0 | 2.5 |
| 2021-12 | 0 | 4.25 |
| 2022-01 | 0 | 1.6 |
| 2022-02 | 0 | 1.4 |
| 2022-03 | 0 | 3.4 |
| 2022-04 | 0 | 1.33 |
| 2022-06 | 0 | 2.77 |
| 2022-07 | 0 | 3 |
| 2022-08 | 1 | 2.17 |
| 2022-09 | 0 | 2.17 |
| 2022-10 | 0 | 1.33 |
| 2022-11 | 0 | 2.82 |
| 2022-12 | 0 | 1.17 |
| 2023-01 | 0 | 4.57 |
| 2023-02 | 0 | 2.14 |
| 2023-03 | 0 | 3.57 |
| 2023-04 | 0 | 10.1 |
| 2023-05 | 0 | 6.29 |
| 2023-06 | 0 | 4.4 |
| 2023-07 | 0 | 3.22 |
| 2023-08 | 0 | 1.75 |
| 2023-09 | 0 | 2 |
| 2023-10 | 0 | 1.33 |
| 2023-11 | 0 | 2.33 |
| 2023-12 | 0 | 1.8 |
| 2024-01 | 0 | 1.17 |
| 2024-02 | 0 | 1 |
| 2024-03 | 0 | 1.33 |
| 2024-04 | 0 | 1.75 |
| 2024-05 | 1 | 2 |
| 2024-06 | 0 | 1 |
| 2024-07 | 0 | 1.6 |
| 2024-08 | 0 | 1 |
| 2024-09 | 0 | 1.25 |
| 2024-10 | 0 | 1.67 |
| 2024-11 | 0 | 3 |
| 2024-12 | 0 | 1 |
| 2025-01 | 0 | 1.6 |
| 2025-02 | 0 | 1.33 |
| 2025-03 | 0 | 1.5 |
| 2025-04 | 0 | 2 |
| 2025-05 | 0 | 2.67 |
| 2025-06 | 0 | 5.67 |
| 2025-07 | 0 | 1.5 |
| 2025-08 | 0 | 1.25 |
| 2025-09 | 0 | 1.67 |
| 2025-10 | 0 | 1 |
| 2025-11 | 0 | 1 |
| 2025-12 | 0 | 1 |
| 2026-01 | 0 | 1.5 |
| 2026-02 | 0 | 1 |
| 2026-03 | 0 | 1 |
| 2026-04 | 0 | 1 |
| 2026-05 | 0 | 1 |
| 2026-06 | 0 | 1 |
Failure-mode summaryAI-generated
3 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2018-02-14 | Z-1006-2018 | Class II | Terminated | 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.Distribution: worldwide | 587 systems | code info di |
| 2015-08-05 | Z-2440-2015 | Class II | Terminated | ExacTrac 6.0 Patient Positioning System: Display of potentially incorrect Digitally Reconstructed Radiograph (DRR) for x-ray correction and verification.Distribution: 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. | 361 systems | clearance family |
| 2015-02-16 | Z-1316-2015 | Class II | Terminated | 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.Distribution: Worldwide Distribution - USA and to the countries of : Australia, Austria, Canada Denmark, France, Germany, Hong Kong, Japan, Russia, Singapore, South Korea and United Kingdom. | 24 systems (US); 36 systems (Foreign) | clearance family |
| 2014-06-24 | Z-2146-2014 | Class II | Terminated | When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow conditions ExacTrac v.6.0.4 might move the patient to an unintended isocenter position, despite displaying the green "OK" icon. If this anomaly occurs and is not detected by the user, the radiation treatment dose at the linear accelerator may be delivered to the unintended target position.Distribution: Worldwide Distribution - USA including CA, CT, and IL; Internationally to France, Germany, Japan, Netherlands, Russia, and Slovenia. | 15 systems | clearance family |
| 2014-02-24 | Z-1513-2014 | Class II | Terminated | When using multiple radiation treatment targets within a single plan, the ExacTrac v.6.0.3 might position the patient to an unintended radiation treatment point. As a result, there is a possibility that the radiation treatment dose may be delivered to the unintended target position.Distribution: Worldwide Distribution -- USA, including the states of CA, IN, LA, MA, OH, TX, and WI, and the countries of Australia, China, France, Germany, Japan, Netherlands, and the United Kingdom. | 41 systems (13 systems in US; 28 systems to foreign countries) | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2024-05-07 | 8043933-2024-00030 | Injury | Available | exact di |
| 2022-08-24 | 8043933-2022-00049 | Injury | Available | exact di |
| 2020-08-28 | 8043933-2020-00043 | Malfunction | Available | exact di |
Regulatory clearances
- 510(k)K120789Substantially equivalent (SESE) · 2012-08-14clearance family
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-02-20 | NAI | No action indicated | Brainlab SE | 0 |
| 2025-02-20 | NAI | No action indicated | Brainlab SE | 0 |
| 2016-02-25 | NAI | No action indicated | Brainlab SE | 0 |
| 2016-02-25 | NAI | No action indicated | Brainlab SE | 0 |
| 2013-06-21 | VAI | Voluntary action indicated | Brainlab SE | 3 |
| 2013-06-21 | VAI | Voluntary action indicated | Brainlab SE | 3 |
| 2011-05-27 | NAI | No action indicated | Brainlab SE | 0 |
| 2011-05-27 | NAI | No action indicated | Brainlab SE | 0 |
Similar devices
- EPTWT410120 PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
- "FC23-C ""Farmer"" type ion chamber " IBA Dosimetry GmbH
- "FC23-C ""Farmer"" type ion chamber" IBA Dosimetry GmbH
- "FC65-G ""Farmer"" type ion chamber" IBA Dosimetry GmbH
- "FC65-G ""Farmer"" type ion chamber" IBA Dosimetry GmbH
- "FC65-P ""Farmer"" type ion chamber" IBA Dosimetry GmbH
- "FC65-P ""Farmer"" type ion chamber" IBA Dosimetry GmbH
- "MLIC ""Zebra"" kpl." IBA Dosimetry GmbH
- "MLIC LE ""Giraffe"" kpl." IBA Dosimetry GmbH
- .decimal Blocking Tray DECIMAL, INC.
- 120 Leaf Assy, MLC Head VARIAN MEDICAL SYSTEMS, INC.
- 206 Electrometer CNMC CO., INC.
Select up to two to place side-by-side with this device.