Aug

2007

Cl II ISOLOC 4.2 Software

Company:Northwest Medical Physics Equipment, Inc
Date of Enforcement Report:8/15/2007
Class:ll

PRODUCT
ISOLOC 4.2 Software Part Number NT-NW-425-520. Radiation treatment software, Recall # Z-1147-2007p>
REASON
When the ISOLOC (Version 4.2) profile distance unit is set to “centimeter” and the user clicked the “back” button in the digitizer window, the marker and target coordinates in the localization window erroneously display values ten times greater than the correct values.

RECALLING FIRM/MANUFACTURER
Northwest Medical Physics Equipment, Inc., Everett, WA, by e-mail on May 31, 2005. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
85 units

DISTRIBUTION
Nationwide, Korea, Spain, and UK

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II ISOLOC 4.2 Software

Amy Sellers

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