Brainlab Spine & Trauma 3D Navigation Software Recall for Display Error
Brainlab AG is recalling Spine & Trauma 3D Navigation 1.0 software because it may display fixed image planes instead of the desired inline view, potentially preventing surgeons from determining instrument position.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 I, which mandates a minimum severity score of 4 per the rubric, as it involves a software defect that could prevent surgeons from determining instrument position during surgery.
Plain-English summary
Brainlab AG is recalling 148 units of the Spine & Trauma 3D Navigation 1.0 software, which is a subpart of the Navigation Software Spine & Trauma 3D, Version 3.0 system. The software is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. The recall covers units distributed in the United States and 24 other countries, including Australia, Canada, Germany, and the United Kingdom.
The recall was initiated because the affected software application might unexpectedly display a navigated instrument in an axial, coronal/sagittal (ACS) view representation with fixed planes in the image reconstruction, rather than the desirable Inline View. This issue might occur after a crash restore or after changing between different navigation workflows during the same patient treatment. This display error could lead to the surgeon being unable to determine the position of the navigated instrument.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this software defect. The recall is classified as Class I by the FDA.
The recalled product
- Product
- Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Use The Spine & Trauma Navigation System is intended as an intraoperative image-guided localization system to enable minimally invasive surgery.
- Manufacturer
- Brainlab AG
- Affected units
- 148
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)
- Version 1.0.0.249
- GTIN 04056481140328
Distribution
Distributed nationwide across the United States.
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