Agency classClass IIOur severity:High FDA (Devices)·Z-1259-2023·Announced 2023-03-22

Radiation Therapy Software May Not Properly Execute Heart-Protection Breath Hold

Brainlab ExacTrac Dynamic software used in charged-particle radiation therapy systems may not properly execute Deep Inspiration Breath Hold (DIBH) functionality, a heart-protection technique. The issue affects 56 systems across the United States.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 is a medical device with potential for serious harm (radiation therapy safety) classified as FDA Class II. While the hazard is significant—software malfunction could result in unintended cardiac radiation exposure—no actual illnesses or injuries have been reported, placing it at Score 3 per the rubric.

Plain-English summary

Brainlab AG is recalling the ExacTrac Dynamic software used in charged-particle radiation therapy systems (models 20910-01E and 20910-01F). The software's Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when using a standard-workflow Treatment Template. DIBH is a breath-holding technique used during radiation therapy to help protect the heart from radiation exposure.

If the DIBH function does not work correctly, patients may not receive the intended heart protection during treatment. This could result in unintended exposure of heart tissue to radiation during cancer treatment.

The affected systems are distributed across 22 U.S. states: Arizona, Arkansas, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Mississippi, Missouri, New Jersey, New York, North Carolina, North Dakota, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, and Washington. A total of 56 systems have been distributed to medical facilities in these states.

Healthcare facilities using these systems should contact Brainlab AG for information about corrective software updates or other remedial measures. Patients who are currently undergoing or scheduled for treatment with these systems should discuss this recall with their healthcare provider to understand any potential impact on their treatment plan.

The recalled product

Product: Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Manufacturer: Brainlab AG
Category: Medical Device — Radiation Therapy System
Hazard: software-malfunction
unintended-radiation-exposure
Affected units: 56

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)

Versions 1.1.0 and 1.1.1
GTIN: 04056481143978.

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically:

Same manufacturer · Brainlab AG

See all →

High
Medical Device Software May Merge Patient Records Without Notification
FDA (Devices) · 2025-03-26
High
Surgical navigation system recalled for potential mechanical instability
FDA (Devices) · 2023-04-05
High
ExacTrac Dynamic Software Yaw Angle Error May Affect Radiotherapy Positioning
FDA (Devices) · 2022-03-16
High
Radiotherapy positioning software may delay patient movement display
FDA (Devices) · 2021-06-16
Severe
Brainlab ExacTrac Dynamic Radiation Therapy System Software Recall
FDA (Devices) · 2021-03-17

Same hazard · software malfunction