Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Isoloc software Versions 6.5 and 4.5, Part Number NT-NW-425-520. Software for image guided radiation therapy.

FDA Recall Z-1145-2007 · Posted 2007-08-08

Recalling FirmNorthwest Medical Physics Equipment Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2006-01-02
Date Terminated2011-04-19
Product Quantity132

Reason for Recall

Isoloc version 6.5 and 4.5 software issued a false warning message regarding Gantry angles when set to "Anatomic Landmark" setting.

Firm Action

Software to fix the described problem was written and customers contacted by e-mail on 01/06/2006 that a software patch, titled 01022006 was available to their customers on the firm's internet website.

Root Cause

Software design

Distribution Pattern

Nationwide, 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.

↑