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U.S. Department of Health and Human Services

Class 2 Device Recall ISOLOC

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  Class 2 Device Recall ISOLOC see related information
Date Initiated by Firm April 07, 2006
Date Posted August 08, 2007
Recall Status1 Terminated 3 on April 19, 2011
Recall Number Z-1146-2007
Recall Event ID 38355
510(K)Number K904908  
Product Classification radiotherapy treatment software - Product Code IYE
Product ISOLOC 6.5 Software Part Number NT-NW-425-520. Software for radiotherapy treatment.
Code Information ISOLOC 6.5 version, Part Number NT-NW-425-520
Recalling Firm/
Manufacturer		 Northwest Medical Physics Equipment Inc
1910 120th Pl SE, Suite 101
Everett WA 98208
For Additional Information Contact
425-672-2841
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Software design
Action Software to fix the problems was written and software users were notified of the availability by e-mail on 04/07/2006. They could download the fixed software from the firm's internet website.
Quantity in Commerce 141 copies
Distribution Customers in USA, Korea, Spain and UK.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = NORTHWEST MEDICAL PHYSICS CENTER
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