Z-1846-2021Class II

ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 -

Name: Z-1846-2021 ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 -
Creator: Brainlab AG
Published: 2021-05-14
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2021-05-14 / Terminated / root cause: software

FDA source

Brainlab AG began a recall of ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately... on 2021-05-14. FDA classified it as Class II and gives the reason as "Display of potential patient movement might be delayed to the user for high dose treatments". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1846-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-14
Posted: 2021-06-10
Terminated: 2023-03-20
Recalling firm: Brainlab, Inc.
Product: ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position, and to provide a beam hold signal in case of a deviations in order to treat lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Display of potential patient movement might be delayed to the user for high dose treatments.
Root cause tag: software
FDA root cause: Software design
Action: An Urgent Field Safety Notice/Product Notification dated 4/29/2021 was issued on 5/14/2021 via email explaining the safety issue and letting the customer know that this issue is in addition to the previous notification of 9/8/2020 which has now expanded to versions 1.0.1 and 1.0.2.
Quantity in commerce: 22 systems in the U.S.
Distribution: US Nationwide distribution in the states of AZ, AR, CA, FL, IN, NJ, NY, NC, OR, PA, and TX. There was no government/military distribution.
Product codes and lots: Version 1.02, GTIN 04056481142315

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1846-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1846-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-10

Product code IYE

K203173Class IIExacTrac DynamicBrainlab AG / cleared 2020-11-12

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)