ClearanceBrief
Recall Z-1145-2007 ยท IYE Accelerator, Linear, Medical

Northwest Medical Physics Equipment Inc

Isoloc software Versions 6.5 and 4.5, Part Number NT-NW-425-520. Software for image guided radiation therapy.

DateAug 8, 2007 (initiated Jan 2, 2006)
StatusTerminated
ReasonIsoloc version 6.5 and 4.5 software issued a false warning message regarding Gantry angles when set to "Anatomic Landmark" setting.
Root causeSoftware design
ActionSoftware to fix the described problem was written and customers contacted by e-mail on 01/06/2006 that a software patch, titled 01022006 was available to their customers on the firm's internet website.
Quantity132
DistributionNationwide, Korea, Spain, and UK.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K904908STEREOTACTIC IRRADIATION SYSTEM
Northwest Medical Physics Center, Jun 6, 1991