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 6.0 and 4.2. Part Number NT-NW-425-520. Image guided radiotherapy treatment software.

FDA Recall Z-1152-2007 · Posted 2007-08-08

Recalling FirmNorthwest Medical Physics Equipment Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2005-04-28
Date Terminated2011-04-20
Product Quantity84

Reason for Recall

When ISOLOC version 6.0 and 4.2 distance unit is set to centimeter, the localization coordinates were rounded to the nearest millimeter which could affect positioning by 0.5 mm.

Firm Action

Software to fix the described problems was written and customers contacted by e-mail on 04/28/2005, that a software patch, titled 04282005, 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.

↑