Reported Feb 19, 2014 · Terminated
BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally…
Brainlab AG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Brainlab AG · Kapellenstrasse 12 · Feldkirchen, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- Model/Catalog Code55830-25A Instrument Star Unit ML
- Serial Numbers (US Devices)
1205112007120511201012051120111205112013120511201412051120191205112021120511202912051120341205112045
- Serial Numbers (Non-US Devices)
120511200412051120061205112008120511200912051120151205112016120511201712051120181205112020120511202312051120251205112026120511202712051120301205112032
- Amount recalled
- 25 units
Where it was sold
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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