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U.S. Department of Health and Human Services

Class 2 Device Recall VVsky Navigation Platform

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  Class 2 Device Recall VVsky Navigation Platform see related information
Date Initiated by Firm November 12, 2007
Date Posted September 17, 2008
Recall Status1 Terminated 3 on July 24, 2009
Recall Number Z-2209-2008
Recall Event ID 48682
510(K)Number K023651  
Product Classification Radiation Therapy Treatment System - Product Code MUJ
Product VectorVision (VV) Sky Navigation Platform (19" Computer Rack); the 19" computer rack is a component of the VVsky Vario, BrainSUITE iMRI, BrainSUITE NET and BrainSUITE iCT systems; BrainLab AG, Kapellenstrasse 12, 85622 Feldkirchen, Germany

Intended to be an intraoperative image guided localization system to enable minimally invasive surgery. Indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure can be identified to relative to a CT, CTA, X-ray, MR, MRA and ultrasound based model of the anatomy.
Code Information VVsky Art. No. 50945; all VVsky products with Data Billboards and/or microscope integrations and/or Device Connections Panels (Wall Panels)
Recalling Firm/
Manufacturer		 Brainlab AG
Ammerthalstrasse 8
Kirchheim B. Muenchen Germany
For Additional Information Contact Ms. Kate Franco
800-597-5911
Manufacturer Reason
for Recall		 Diameter of cables used for installation are to small for the applied current. If an internal short circuit is produced the medical power supply will not shut down automatically and will continue to deliver current, which could result in overheating cables.
FDA Determined
Cause 2		 Component design/selection
Action BrainLAB sent Product Notification letters dated 11/12/07 to their VectorVision Sky end users, informing them of the possible overload of electrical cables in VVsky products with Data Billboards and/or microscope integrations and/or Device Connections Panels (Wall Panels). The users were requested to perform an inspection of the medical power supplies and cabling on a regular basis. If anything suspicious is noted, they were directed to shut down the entire system and contact BrainLAB immediately. BrainLAB contacted each account shortly after the sending of the letter to arrange for the installation of small fuses/circuit breakers according to the specific load limits per device, which will open the circuit in case of overload on faulty circuits, and to exchange the low voltage cables that directly connect the medical power supply from 1.5 mm2 to 2.5 mm2 thickness to withstand the full 20 amp current in case of a failure. Any questions were directed to BrainLAB's customer hotline at 1-800-597-5911.
Quantity in Commerce 23 units
Distribution Nationwide Distribution --- including states of Arizona, Connecticut t, Idaho, Massachusetts, Michigan, Minnesota, New York, Ohio, Pennsylvania, Texas, Virginia and Wisconsin.
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 = MUJ and Original Applicant = BRAINLAB AG
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