ClearanceBrief
Recall Z-1153-2007 ยท IYE Accelerator, Linear, Medical

Northwest Medical Physics Equipment Inc

ISOLOC Software Version 6.0, Localization software for determining treatment machine position (to position patients) for high accuracy radiotherapy.

DateAug 8, 2007 (initiated Apr 11, 2005)
StatusTerminated
ReasonWhen ISOLOC version 6.0 was used in the centimeter mode, the display in the couch moves window had a rounding error relative to the Portal Image Marker window of up to 0.5 mm.
Root causeSoftware design
ActionSoftware to fix the described problem was written and customers contacted by e-mail on 04/11/2005, that a software patch, titled 04112005, was available to their customers on the firm's internet website.
Quantity84
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