Agency classClass IIOur severity:High FDA (Devices)·Z-1707-2014·Announced 2014-06-11

Brainlab ExacTrac 5.5 Image Processing System Recalled for Plan Blending Error

Brainlab AG is recalling ExacTrac 5.5 image processing systems because a specific workflow may generate unintended blends of separate patient treatment plans.

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: The recall involves a medical device defect that could lead to incorrect treatment planning, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Brainlab AG is recalling 40 ExacTrac 5.5 Image Processing Systems used for patient positioning in radiation therapy or radiosurgery. The recall involves software version 5.5.5 and specific upgrade kits.

The recall is due to a software defect where using a specific plan update workflow with a non-Brainlab treatment planning system may generate an unintended blend of two initially separate plans for the same patient. This could result in incorrect treatment planning data.

The affected systems are distributed worldwide, including in the United States (AZ, AR, CA, FL, KY, MA, NE, NY, TN, TX) and in Argentina, Australia, Brazil, Finland, India, Japan, Netherlands, Oman, Russia, and Taiwan. Healthcare facilities should contact Brainlab AG for instructions on how to resolve the issue.

The recalled product

Product: ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.
Manufacturer: Brainlab AG
Category: Medical Device — Radiation Therapy Equipment
Hazard: software-defect
treatment-error
Affected units: 40

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 (14)

2) 20820 ET SOFTWARE UPDATE 5.0 TO 5.5
3) 49905D EXACTRAC COMPLETE SYSTEM UPG 3.X TO 5.5
4) 49908C EXACTRAC SOFTWARE UPGRADE 3.X TO 5.5
5) 49909A EXACTRAC SOFTWARE UPGRADE 4.X TO 5.5
6) 49918 ET SOFTWARE UPDATE 5.5.X TO 5.5.5
7) 49919 ET SOFTWARE UPDATE 5.0.X TO 5.5.5
8) 49660A ET INFRARED SOFTWARE 5.5.5
9) 49961 ET DATA PREP/REVIEW SYSTEM
10) 49986 ET SYSTEM UPGRADE 3.X TO 5.5 NEW VAULT
11) 49987 ET SYSTEM UPGRADE 4.X TO 5.5 NEW VAULT
12) 49988 ET SYSTEM UPGRADE 4.X TO 5.5 SAME VAULT
13) 49989 ET SYSTEM UPGRADE 5.0 TO 5.5 NEW VAULT
14) 49990 ET SYSTEM UPGRADE 5.0 TO 5.5 SAME VAULT
15) 49991 ET SYSTEM UPGRADE 5.5 TO 5.5 NEW VAULT

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Same manufacturer · Brainlab AG

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Same hazard · software defect