Brainlab AG Olof-palme-str. 9 Munich Germany 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. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.

Recommended Action

Per FDA guidance

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.

Distribution

As reported by FDA

AZ, AR, CA, CO, FL, GA, IN, KY, MD, MS, MO, NJ, NY, NC, OK, OR, PA, TX, VA, WA