The Recall Desk
HighFDA (Devices)·Z-1846-2021·Announced 2021-06-16

Radiotherapy positioning software may delay patient movement display

Brainlab's ExacTrac Dynamic radiotherapy positioning software may delay display of patient movement during high-dose treatments, risking treatment precision errors. 22 systems affected across 11 U.S. states.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II device poses a risk of harm through delayed display of critical patient position information during high-risk radiotherapy procedures, potentially leading to treatment positioning errors. No illnesses or injuries have been reported, placing this under "risk-of-harm products where injury has not yet been reported."

Plain-English summary

Brainlab AG is recalling ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer version 1.0.2. This software is used to position patients during stereotactic radiosurgery and radiotherapy procedures and to monitor patient position during treatment.

A software defect may cause the display of potential patient movement to be delayed to the user during high-dose treatments. Delayed notification of patient movement could lead to positioning errors or reduced treatment precision.

22 systems have been distributed across the United States, primarily in Arizona, Arkansas, California, Florida, Indiana, New Jersey, New York, North Carolina, Oregon, Pennsylvania, and Texas. Healthcare facilities using this software should contact Brainlab to determine if their system is affected and what remediation steps are available.

Patients who have received treatment with this software should contact their healthcare provider with questions about their treatment delivery and positioning during their procedures.

The recalled product

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
Manufacturer
Brainlab AG
Category
Medical Device — Radiotherapy Positioning Software
Hazard
Affected units
22

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Version 1.02
  • GTIN 04056481142315

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

Related recalls

Same manufacturer · Brainlab AG

See all →