Z-0733-2022Class II

ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD...

Name: Z-0733-2022 ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD...
Creator: Brainlab AG
Published: 2022-02-25
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2022-02-25 / Open, Classified / root cause: software

FDA source

Brainlab AG began a recall of 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... on 2022-02-25. FDA classified it as Class II and gives the reason as "The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0733-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-02-25
Posted: 2022-03-08
Recalling firm: Brainlab, Inc.
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.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
Root cause tag: software
FDA root 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.
Product codes and lots: Software versions 1.0.0, 1.0.1, 1.0.2, 1.0.3, GTIN 04056481142315.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0733-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0733-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-16	2022-03-08

Product code IYE

K211939Class IIExacTrac DynamicBrainlab AG / cleared 2021-07-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)