Brainlab ExacTrac 6.0 Radiation Positioning System Recalled for Targeting Error
Brainlab AG is recalling ExacTrac 6.0 systems because they may position patients to unintended radiation targets, potentially delivering dose to the wrong location.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves the potential delivery of radiation to an unintended target, which constitutes a significant injury risk, aligning with the 'Severe' criteria for significant injury reports or high-risk medical device defects.
Plain-English summary
Brainlab AG is recalling ExacTrac 6.0 patient positioning and monitoring systems, including specific software upgrade kits and data preparation systems. The recall involves 41 systems distributed worldwide, with 13 located in the United States and 28 in foreign countries.
The recall is due to a software defect in version v.6.0.3. When multiple radiation treatment targets are used within a single plan, the system may position the patient to an unintended radiation treatment point. This error creates a possibility that the radiation treatment dose may be delivered to the unintended target position.
Affected systems are distributed in the United States (including California, Indiana, Louisiana, Massachusetts, Ohio, Texas, and Wisconsin) and in Australia, China, France, Germany, Japan, the Netherlands, and the United Kingdom. Healthcare facilities using these systems should contact Brainlab AG for instructions on how to resolve the issue.
The recalled product
- Product
- ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49927B ET…
- Manufacturer
- Brainlab AG
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 (1)
- ExacTrac version v.6.0.3.
Distribution
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