Recall Z-0967-2014 ยท HAW Neurological Stereotaxic Instrument
Brainlab AG
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 stere
| Date | Feb 10, 2014 (initiated Nov 15, 2013) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Nonconforming Material/Component |
| Action | BrainLab send a A FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter dated November 15, 2013, to all affected customers. The letter requested that customers verify that they are in possession of one or more of the affected devices, remove the affected devices from use, and that Brainlab will provide replacement parts for the customers. Customers with questions can contact Brainlab by telephone at 1-800-597-5911 or via e-mail at us.support@brainlab.com. For questions regarding this recall call 800-597-5911. |
| Quantity | 25 units |
| Distribution | Worldwide Distribution - USA including CA, MN, NC, NY, OH, TX and DC. Internationally to Australia, Chile, Germany, Hungary, Italy, Panama, Qatar, Russia, Thailand, United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053159 | VECTORVISION SPINE Brainlab AG, Jun 6, 2006 |