Brainlab Ultrasound Navigation Software Recalled for Image Width Limitation
Brainlab AG is recalling Ultrasound Navigation Software 1.0 and related integration software because the system does not support modifying the probe's image width.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a functional software limitation (inability to modify image width) rather than a direct physical injury or contamination, fitting the criteria for moderate severity.
Plain-English summary
Brainlab AG is recalling Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x. The recall involves 271 units of software intended to be an intra-operative image guided localization system to enable minimally invasive surgery.
The recall was initiated because the software does not support the modification of the probe's image width. This limitation affects the functionality of the ultrasound navigation system during surgical procedures.
The affected software was distributed worldwide, including in the United States and numerous international countries. Users of this software should contact Brainlab AG for further instructions regarding the recall and potential remediation.
The recalled product
- Product
- Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended to be an intra-operative image guided localization system to enable minimally invasive surgery.
- Manufacturer
- Brainlab AG
- Hazard
- Affected units
- 271
Distribution
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