Brainlab Spine & Trauma 3D 2.0 Navigation Software Recalled for Registration Defect
Brainlab AG is recalling 133 units of Spine & Trauma 3D 2.0 Navigation Software due to a defect in the fluoro match registration function.
What this means for you
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 is classified as FDA Class II. The product is a medical device used in spinal surgery, and a defect in the navigation software poses a risk of harm to patients during the procedure, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Brainlab AG is recalling 133 units of the Spine & Trauma 3D 2.0 Navigation Software, Catalog Number 22264. This software is an intraoperative image-guided localization system used to enable minimally invasive spinal surgeries by displaying the position and orientation of instruments.
The recall is due to a defect in the "fluoro match registration" function. This function allows users to match CT data sets to the current patient anatomy visible on fluoroscopic images during surgery. The source text indicates a defect in this registration function in combination with a digitally integrated component, though the specific nature of the failure is not fully detailed in the provided excerpt.
The affected units were distributed worldwide, including in the United States (AZ, CA, GA, IL, IN, LA, MA, MI, NY, NC, OH, PA, TN, TX, WI) and numerous international locations. Healthcare providers and facilities that have purchased or received this software should stop using the affected units and contact Brainlab AG for further instructions on remediation or replacement.
The recalled product
- Product
- Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264
- Manufacturer
- Brainlab AG
- Affected units
- 133
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 (20)
- Catalog Number: 22264
- Serial Numbers: 000000000038012001
- 000000000060912001
- 000000000189912001
- 000000000224912001
- 000000000235512001
- 000000000282912001
- 000000000313612001
- 000000000319412001
- 000000000351112001
- 000000000356912001
- 000000000367212001
- 000000000433712001
- 000000000482012001
- 000000000502812001
- 000000000645612001
- 000000000731112001
- 000000000837312001
- 000000000898312001
- 000000000956812001
Distribution
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