Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BrainLAB's VectorVision spine is intended for use as an intraoperative Recalled by Brainlab AG Due to Brainlab has determined that pins of thee Instrument...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Brainlab AG directly.
Affected Products
BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative image data that is processed by a VectorVision workstation. The system is indicated for any medical condition in which the use of stereoscopic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to a CT, x-ray, or MR-based model of the anatomy.
Quantity: 25 units
Why Was This Recalled?
Brainlab has determined that pins of thee Instrument Star Unit ML (Calibration with ICM4) with specific serial numbers might have been made of an incorrect material that is not suitable for the necessary disinfection and sterilization of the product. If corrosion occurs and is not detected by the user, and the device is used during surgery, corroded particles of the pin could, directly or indirect
Where Was This Sold?
This product was distributed to 7 states: CA, MN, NY, NC, OH, TX, DC
About Brainlab AG
Brainlab AG has 39 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report