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Terminated

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

FDA Recall Z-1147-2007 · Posted 2007-08-08

Recalling FirmNorthwest Medical Physics Equipment Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2005-05-31
Date Terminated2011-04-19
Product Quantity85

Reason for Recall

When 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.

Firm Action

Software 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.

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.

K904908STEREOTACTIC IRRADIATION SYSTEMNorthwest Medical Physics Center · 1991-06-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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