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U.S. Department of Health and Human Services

Class 2 Device Recall BrainLAB's VectorVision spine

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  Class 2 Device Recall BrainLAB's VectorVision spine see related information
Date Initiated by Firm November 15, 2013
Date Posted February 10, 2014
Recall Status1 Terminated 3 on March 13, 2017
Recall Number Z-0967-2014
Recall Event ID 67017
510(K)Number K053159  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
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.
Code Information 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
Recalling Firm/
Manufacturer		 Brainlab AG
Kapellenstrasse 12
Feldkirchen Germany
For Additional Information Contact Customer Hotline
800-5975911
Manufacturer 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 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HAW and Original Applicant = BRAINLAB AG
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