Z-2209-2008

VectorVision (VV) Sky Navigation Platform (19" Computer Rack); the 19" computer rack is a component of the...

Name: Z-2209-2008 VectorVision (VV) Sky Navigation Platform (19" Computer Rack); the 19" computer rack is a component of the...
Creator: Brainlab AG
Published: 2007-11-12
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2007-11-12 / Terminated / root cause: design

FDA source

Brainlab AG began a recall of VectorVision (VV) Sky Navigation Platform (19" Computer Rack); the 19" computer rack is a component of the VVsky Vario, BrainSUITE iMRI, BrainSUITE NET and... on 2007-11-12. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2209-2008
Status: Terminated
Initiated: 2007-11-12
Posted: 2008-09-17
Terminated: 2009-07-24
Recalling firm: Brainlab, Inc.
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.
Product code: MUJ System, Planning, Radiation Therapy Treatment
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.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: VVsky Art. No. 50945; all VVsky products with Data Billboards and/or microscope integrations and/or Device Connections Panels (Wall Panels)

Product code MUJ

K023651Class IIVectorvision Cranial/entBrainlab AG / cleared 2004-02-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)