Recall Z-2209-2008 ยท MUJ System, Planning, Radiation Therapy Treatment
Brainlab AG
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
| Date | Sep 17, 2008 (initiated Nov 12, 2007) |
| Status | Terminated |
| 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. |
| 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 ins |
| Quantity | 23 units |
| Distribution | Nationwide Distribution --- including states of Arizona, Connecticut t, Idaho, Massachusetts, Michigan, Minnesota, New York, Ohio, Pennsylvania, Texas, Virginia and Wisconsin. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023651 | VECTORVISION CRANIAL/ENT Brainlab AG, Feb 17, 2004 |