Inc., Cl II Northwest Medical Physics Equipment

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

PRODUCT
ISOLOC 6.5 Software Part Number NT-NW-425-520. Software for radiotherapy treatment, Recall # Z-1146-2007p>
REASON
This correction was for several software bugs which caused image format problems; incorrect ruler display; software crashes; failure to update pixel spacing; display of unattainable treatment table positions; failure to update gantry angles; wrong shifts for two of three axes of treatment table movement.

RECALLING FIRM/MANUFACTURER
Northwest Medical Physics Equipment, Inc., Everett, WA, by e-mail on April 7, 2006. Firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
141 units

DISTRIBUTION
Nationwide, Korea, Spain, and UK

About the author

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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