| Date Initiated by Firm |
February 14, 2018 |
| Create Date |
March 14, 2018 |
| Recall Status1 |
Terminated 3 on May 17, 2021 |
| Recall Number |
Z-1006-2018 |
| Recall Event ID |
79266 |
| 510(K)Number |
K120789
|
| Product Classification |
Accelerator, linear, medical - Product Code IYE
|
| 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. |
| Code Information |
UDI: GTIN for ExacTrac 6.0 and 6.1 is not applicable GTIN for ExacTrac 6.2 is: 04056481000264 GTIN for ExacTrac 6.5 is: 04056481138400 License No. Description 20833 EXACTRAC 6.0 IR POSITIONING SOFTWARE 20834 EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE 20835 EXACTRAC 6.0 IR MONITORING SOFTWARE 20853 EXACTRAC 6.0 X-RAY LIMITED SOFTWARE 20871 EXACTRAC 6.1 X-RAY POSITIONING SOFTWARE 20872 EXACTRAC 6.1 IR POSITIONING SOFTWARE 20873 EXACTRAC 6.1 X-RAY MONITORING SOFTWARE 20874 EXACTRAC 6.1 X-RAY LIMITED SOFTWARE 20881 EXACTRAC 6.2 X-RAY POSITIONING SOFTWARE 20884 EXACTRAC 6.2 X-RAY LIMITED SOFTWARE 20833A EXACTRAC 6.0 IR POSITIONING SOFTWARE 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 20833C EXACTRAC 6.0 IR POSITIONING SOFTWARE 20833D EXACTRAC 6.0 IR POSITIONING SOFTWARE 20833E EXACTRAC 6.0 IR POSITIONING SOFTWARE 20834A EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE 20834B EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE 20834C EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE 20834D EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE 20834E EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE 20835A EXACTRAC 6.0 IR MONITORING SOFTWARE 20835B EXACTRAC 6.0 IR MONITORING SOFTWARE 20835C EXACTRAC 6.0 IR MONITORING SOFTWARE 20835D EXACTRAC 6.0 IR MONITORING SOFTWARE 20835E EXACTRAC 6.0 IR MONITORING SOFTWARE 20853A EXACTRAC 6.0 X-RAY LIMITED SOFTWARE 20853B EXACTRAC 6.0 X-RAY LIMITED SOFTWARE 20853C EXACTRAC 6.0 X-RAY LIMITED SOFTWARE 20853D EXACTRAC 6.0 X-RAY LIMITED SOFTWARE 20853E EXACTRAC 6.0 X-RAY LIMITED SOFTWARE 20871A EXACTRAC 6.1 X-RAY POSITIONING SOFTWARE 20872A EXACTRAC 6.1 IR POSITIONING SOFTWARE 20873A EXACTRAC 6.1 X-RAY MONITORING SOFTWARE 20874A EXACTRAC 6.1 X-RAY LIMITED SOFTWARE 20881A EXACTRAC 6.5 X-RAY POSITIONING SOFTWARE 20882-02 EXACTRAC 6.2.0 SW LICENSE 20882-02A EXACTRAC 6.2.1 SW LICENSE 20882-02B EXACTRAC 6.5.0 SW LICENSE 20883-02A EXACTRAC 6.2 X-RAY MONITORING SOFTWARE 20883-02B EXACTRAC 6.5 X-RAY MONITORING SOFTWARE 20836 EXACTRAC 6.X VARIAN CBCT LICENSE 20838 EXACTRAC 6.X X-RAY MONITORING LICENSE 25730 ET SW 6.5 - X-RAY MONITORING SUB. FOC 25731 ET SW 6.5 - X-RAY MONITORING SUB. 25734 ET SW - DATA PREP REVIEW 6.5 SUB 48302 ET DATA PREP / REVIEW SYSTEM 48304 ET 6.1 DATA PREP/REVIEW SYSTEM UPG. KIT 48320 ET UPGRADE SOFTWARE 6.0 TO 6.1 48321 ET UPGRADE SOFTWARE 3.X TO 6.1 (IR+XR) 48322 ET UPGRADE SOFTWARE 4.X TO 6.1 (IR+XR) 48327 ET UPGRADE TRUEBEAM 5.5 TO 6.1 LIMITED 48331 EXACTRAC 6.0 LIMITED to 6.1 LIMITED SW 48332 EXACTRAC UPGRADE 6.0 LIMITED TO 6.1 48351 EXACTRAC 6.1 X-RAY MONITORING SOFTWARE 48353 ET SOFTWARE UPDATE 6.0.5 TO 6.0.6 48405 ET SW 6.5 - X-RAY MONITORING 48423 ET UP P&R WORKSTATION 6.0.X to 6.5 (FULL 48440 EXACTRAC UPG SOFTWARE 6.0 TO 6.5 48441 EXACTRAC UPG SOFTWARE 6.0 TO 6.5 P&R 48442 EXACTRAC UPGRADE 6.1/2 TO 6.5 48443 EXACTRAC UPG SOFTWARE 6.1/2 TO 6.5 P&R 48444 EXACTRAC UPG SOFTWARE 5.5 TO 6.5 48445 EXACTRAC UPG SOFTWARE 5.5 TO 6.5 P&R 48446 EXACTRAC UPG 6.1/2 TO 6.5 SERVICE CUSTOM 48447 EXACTRAC UPG 6.1/2 TO 6.5 SERVICE CU P&R 49926 ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49927 ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR) 49931 ET 6.0 UPGRADE TO X-RAY SNAP MONITORING 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49938 ET SOFTWARE UPDATE 6.0.3TO 6.0.4 49939 ET SOFTWARE UPDATE 6.0.X to 6.0.4 P&R 49971 CBCT IMPORT & ALIGNMENT SOFTWARE 49977 ET GENERATOR UPGRADE HFE/MP TO DUAL HFE 49996 ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY 49997 ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED 20849 EXACTRAC 6.X ADI LOADING LICENSE 20882A ET SW 6.5 - IR POSITIONING 20883A ET SW 6.5 - X-RAY MONITORING STANDALONE 25702 ET SW 6.2 - X-RAY MONITORING SUB. 25710B ET SW - DATA PREP REVIEW SUB. 25722 ET SW 6.2 - X-RAY MONITORING SUB. FOC 25723B ET SW - DATA PREP REVIEW SUB. FOC 48302A ET DATA PREP / REVIEW SYSTEM 48313B ET SW - DATA PREP REVIEW 48320-99 ET UPGRADE SOFTWARE 6.0 TO 6.1 SLA 48323 ET UPGRADE SOFTWARE 5.X TO 6.1 (IR+XR) 48324 ET UPGRADE SOFTWARE X.X TO 6.1 SW ONLY 48326 EXACTRAC UPGRADE 5.5 TO 6.1 BASIC 48340-99A ET SW - UPG 6.X TO 6.2 P&R FOR SER. CUS. 48343 ET UPGRADE SOFTWARE 5.X TO 6.2 (IR+XR) 48345 EXACTRAC UPG 6.X BASIC/LIMITED TO 6.2 48349 ET SW 6.0 - X-RAY POSITIONING CHINA ONLY 48355A ET SW 6.2 - X-RAY MONITORING 48362 EXACTRAC UPG 6.1.X TO 6.2 FOC 48364 EXACTRAC UPG SOFTWARE 6.X TO 6.2 48364-99 ET SW - UPG 6.X TO 6.2 FOR SER. CUS. 48364-99A ET SW - UPG 6.X TO 6.2 FOR SER. CUS. 49892 EXACTRAC 6.1 SYSTEM UPGRADE 49892A EXACTRAC 6.2 SYSTEM UPGRADE 49892B EXACTRAC 6.2 SYSTEM UPGRADE 49898 EXACTRAC 6.1 SYSTEM UPGRADE 49898B EXACTRAC 6.2 SYSTEM UPGRADE 49926A ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49927A ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR) 49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR) 49928 ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR) 49928A ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR) 49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR) 49933 ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED 49933A ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED 49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED 49934 EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49936A ET SOFTWARE UPDATE 6.0.X TO 6.0.4 49936B ET SOFTWARE UPDATE 6.0.X TO 6.0.5 49936C ET SOFTWARE UPDATE 6.0.X TO 6.0.6 49938A ET SOFTWARE UPDATE 6.0.3TO 6.0.5 49938B ET SOFTWARE UPDATE 6.0.3TO 6.0.6 49939A ET SOFTWARE UPDATE 6.0.X to 6.0.5 P&R 49964 ET SYSTEM CONTROL UNIT (1 RACK) 49964B ET SYSTEM CONTROL UNIT (1 RACK) 49973 ET DATA PREP / REVIEW SYSTEM 49973A ET DATA PREP / REVIEW SYSTEM 49973B ET DATA PREP / REVIEW SYSTEM 49996A ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY 49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY 49997A ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED 49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED 49998 ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT 49998A ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT 49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT 70359-01 EXACTRAC 6.0 IR POSITIONING SOFTWARE FOC |
Recalling Firm/
Manufacturer |
Brainlab AG
Olof-Palme-Strasse 9
Munich Germany
|
Manufacturer Reason
for Recall |
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.
|
FDA Determined
Cause 2 |
Other |
| Action |
The firm disseminated their notices by email on 02/14/2018.
The notice requests the following actions:
"User Corrective Action:
Always follow the instructions below during use of ExacTrac Patient Positioning System (versions 6.0, 6.1, 6.2, 6.5) with Auxiliary Device Interface (ADI) and Varian Clinac or Varian TrueBeam:
Do not use beam authorization by ExacTrac via ADI as a safety feature to ensure correct patient positioning before treatment.
For any treatments performed with ExacTrac always verify that ExacTrac confirms the target position by displaying the OK icon. Do not treat the patient if the OK icon is not displayed.
This indicates that the isocenter is in the planned treatment position. The treatment beam should not be activated unless the OK icon is shown.
If using ExacTrac on a Varian Clinac or Varian TrueBeam system equipped with the Auxiliary Device Interface (ADI) always perform treatment in the following sequence:
1. Start the ExacTrac Software and login using your user name and password
2. Load the Plan / Patient on the Varian Treatment Application / Console
3. Open the Plan / Patient on ExacTrac by clicking Open in the message box (refer to Figure 2)
4. Prepare the beam on the Varian Treatment Application / Console
If you intend to perform treatments for which ExacTrac is not used for patient positioning, please click Cancel in the message box to confirm not opening the patient and to continue the treatment without ExacTrac.
ExacTrac can be configured to directly load the patient automatically in ExacTrac if it is opened on the Varian Treatment Application / Console - meaning that the message box (refer to Figure 2) is deactivated. However, this may not be the preferred solution for each user, as automatic loading causes delays in treatment preparation if no positioning via ExacTrac is to be used, since in these cases the patient data has to be closed manually. Please contact your local Brainlab Customer Support Representat |
| Quantity in Commerce |
587 systems |
| Distribution |
worldwide |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = IYE and Original Applicant = BRAINLAB AG
|
