Events

Recall of Device Recall VVsky Navigation Platform

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Brainlab AG.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    48682
  • Event Risk Class
    Class 2
  • Event Number
    Z-2209-2008
  • Event Initiated Date
    2007-11-12
  • Event Date Posted
    2008-09-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-07-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71856
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Radiation Therapy Treatment System - Product Code MUJ
  • Reason
    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.
  • 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.

Device

Device Recall VVsky Navigation Platform
  • Model / Serial
    VVsky Art. No. 50945; all VVsky products with Data Billboards and/or microscope integrations and/or Device Connections Panels (Wall Panels)
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution --- including states of Arizona, Connecticut t, Idaho, Massachusetts, Michigan, Minnesota, New York, Ohio, Pennsylvania, Texas, Virginia and Wisconsin.
  • Product Description
    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.
  • Manufacturer
    Brainlab AG

Manufacturer

Brainlab AG
  • Manufacturer Address
    Brainlab AG, Ammerthalstrasse 8, Kirchheim B. Muenchen Germany
  • Source
    USFDA