ClearanceBrief
Recall Z-1155-2007 ยท IYE Accelerator, Linear, Medical

Northwest Medical Physics Equipment Inc

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

DateAug 9, 2007 (initiated Nov 30, 2004)
StatusTerminated
ReasonWhen ISOLOC Version 4.2 unit is set to centimeter and the user clicks the Reenter button in the digitizer window, the coordinates of the markers and target in the anatomic imaging system erroneously displays values ten times greater than the correct values.
Root causeSoftware design
ActionSoftware to fix the described problem was written and customers contacted by e-mail on 11/30/2004, that a software patch, titled 11302004, was available to their customers on the firm's internet website.
Quantity83
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