Recall Z-0967-2014
Brainlab AG · initiated November 15, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Model/Catalog Code: 55830-25A Instrument Star Unit ML; Serial Numbers (US Devices): 1205112007, 1205112010, 1205112011, 1205112013, 1205112014, 1205112019, 1205112021, 1205112029, 1205112034, 1205112045; Serial Numbers (Non-US Devices): 1205112004, 1205112006, 1205112008, 1205112009, 1205112015, 1205112016, 1205112017, 1205112018, 1205112020, 1205112023, 1205112025, 1205112026, 1205112027, 1205112030, 1205112032
Reason for recall
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
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-0967-2014
- Initiated
- November 15, 2013
- Posted by FDA
- February 10, 2014
- Terminated
- March 13, 2017
- Product code
- HAW – Neurological Stereotaxic Instrument
- 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.
- Recalling firm
- Brainlab AG, Feldkirchen