Class 2 Device Recall ExacTrac Dynamic

• Date Initiated by Firm: February 25, 2022
• Create Date: March 08, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0733-2022
• Recall Event ID: 89662
• 510(K)Number: K211939
• Product Classification: Accelerator, linear, medical - Product Code IYE
• 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.
• Code Information: Software versions 1.0.0, 1.0.1, 1.0.2, 1.0.3, GTIN 04056481142315.
• Recalling Firm/ Manufacturer: Brainlab AG; Olof-palme-str. 9; Munich Germany
• Manufacturer Reason for Recall: The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
• FDA Determined Cause: Software design
• Action: The recalling firm initiated the recall via email on 2/25/2022 with the Urgent Field Safety Notice dated 2/7/2022 attached. The email says to ensure the safe and effective use of the device, the consignee is to reply (1) they have received the Field Safety Notice; (2) the affected device is installed at the hospital and the the addressee of the email is the correct recipient for the communication; and (3) users at the hospital have been made aware of the content and adhere to the User Corrective Action described in the enclosed notification. The email asks the consignee to answer each of the 3 points to ensure the effectiveness of the communication. The notice explained the issue and provided details of specific conditions that are required for the error to occur, the affected workflows, and the magnitude of the potential error. User Corrective Action is provided giving instructions to prevent the issue from occurring. The action provided was: When using the ETD CBCT module, always ensure that during the CBCT X-ray Reference Acquisition step (CBCT offset detection), a treatment beam and not a setup beam is loaded on the Varian treatment console. If a setup beam is loaded, the word Setup will display in the ETD software, and it is not safe to continue. (A figure is provided to show the display. It shows a screen where a setup beam is active and it is not safe to continue and also shows the display of a treatment beam that is active and it is safe to continue.) In this case, the user is to assure they first switch to a treatment beam on the Varian treatment console and confirm the change in the Brainlab ETD software before continuing. Brainlab will provide a software revision of ExacTrac Dynamic with the described issue corrected to all affected customers. Brainlab will actively contact the consignee to schedule the update, starting in May 2022. Appropriate personnel working in the consignee's department are to be made aware of the notification.
• Quantity in Commerce: 205 systems
• Distribution: 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.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = IYE and Original Applicant = Brainlab AG