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Terminated

ISOLOC 6.5 Software Part Number NT-NW-425-520. Software for radiotherapy treatment.

FDA Recall Z-1146-2007 · Posted 2007-08-08

Recalling FirmNorthwest Medical Physics Equipment Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2006-04-07
Date Terminated2011-04-19
Product Quantity141 copies

Reason for Recall

This correction was for several software bugs which caused image format problems; incorrect ruler display; software crashes; failure to update pixel spacing; display of unattainable treatment table positions; failure to update gantry angles; wrong shifts for two of three axes of treatment table movement.

Firm Action

Software to fix the problems was written and software users were notified of the availability by e-mail on 04/07/2006. They could download the fixed software from the firm's internet website.

Root Cause

Software design

Distribution Pattern

Customers in 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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