Agency classClass IIOur severity:High FDA (Devices)·Z-0733-2022·Announced 2022-03-16

ExacTrac Dynamic Software Yaw Angle Error May Affect Radiotherapy Positioning

ExacTrac Dynamic radiotherapy positioning software (versions 1.0.0–1.0.3) may calculate incorrect yaw angle for patient positioning with Varian linear accelerators, potentially affecting cone-beam CT imaging setup accuracy during radiotherapy.

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 an FDA Class II recall affecting radiotherapy positioning software. Although no injuries or illnesses have been reported, the software error creates a risk of incorrect patient positioning during radiation therapy, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

ExacTrac Dynamic is radiotherapy positioning software used to align patients for radiation therapy treatment. Versions 1.0.0, 1.0.1, 1.0.2, and 1.0.3 (model numbers 20910-01, 20910-01A, 20910-01B, and 20910-01C) may calculate the yaw angle (rotational positioning around the vertical axis) incorrectly when setting up cone-beam CT imaging on Varian linear accelerators. This error could provide inaccurate positioning information to clinical staff.

The affected systems comprise 205 units distributed to medical facilities in 20 U.S. states and 25 countries worldwide. No illnesses or injuries have been reported at this time.

The FDA has classified this as a Class II recall, indicating the software error poses a potential risk to patient positioning accuracy during radiation therapy. Facilities using affected ExacTrac Dynamic systems should contact Brainlab AG for software updates or guidance on corrective actions.

The recalled product

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.
Manufacturer: Brainlab AG
Category: Medical Device — Radiotherapy / Radiation Therapy
Hazard: positioning-error
software-accuracy
Affected units: 205

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 (5)

Software versions 1.0.0
1.0.1
1.0.2
1.0.3
GTIN 04056481142315.

Distribution

Distributed in 20 states:

Same manufacturer · Brainlab AG

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