ClearanceBrief
Recall Z-1147-2007 ยท IYE Accelerator, Linear, Medical

Northwest Medical Physics Equipment Inc

ISOLOC 4.2 Software Part Number NT-NW-425-520. Image guided radiation treatment software.

DateAug 8, 2007 (initiated May 31, 2005)
StatusTerminated
ReasonWhen the ISOLOC (Version 4.2) profile distance unit is set to "centimeter" and the user clicked the "back" button in the digitizer window, the marker and target coordinates in the localization window erroneously display values ten times greater than the correct values.
Root causeSoftware design
ActionSoftware to fix the described problems was written and customers contacted by e-mail on 05/31/2005, that a software patch, titled 05312005 was available on the firm's internet website.
Quantity85
DistributionWorldwide, including USA, 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