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Terminated

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

FDA Recall Z-1153-2007 · Posted 2007-08-08

Recalling FirmNorthwest Medical Physics Equipment Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2005-04-11
Date Terminated2011-04-19
Product Quantity84

Reason for Recall

When 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.

Firm Action

Software 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.

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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