ISOLOC Software Version 4.2, Part Number NT-NW-425-520. Image guided radiation treatment software.
FDA Recall Z-1155-2007 · Posted 2007-08-09
Recalling FirmNorthwest Medical Physics Equipment Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2004-11-30
Date Terminated2011-04-19
Product Quantity83
Reason for Recall
When 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.
Firm Action
Software 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.
Root Cause
Software design
Distribution Pattern
Worldwide, including USA, Korea, Spain, and UK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.