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Terminated

ISOLOC Software Version 6.0, Part Number NT-NW-425-520. Localization software for radiotherapy treatment system.

FDA Recall Z-1154-2007 · Posted 2007-08-08

Recalling FirmNorthwest Medical Physics Equipment Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2004-12-30
Date Terminated2011-04-19
Product Quantity79

Reason for Recall

When ISOLOC version 6.0 software was used in the Anatomic Landmark mode, the couch moves display in the Couch Translator window was incorrect.

Firm Action

Software to fix the described problem was written and customers contacted by e-mail on 12/30/2004 that a software patch, titled 12302004 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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