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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 December 30, 2004
Date Posted August 08, 2007
Recall Status1 Terminated 3 on April 19, 2011
Recall Number Z-1154-2007
Recall Event ID 38363
510(K)Number K904908  
Product Classification localization software for radiotherapy - Product Code IYE
Product ISOLOC Software Version 6.0, Part Number NT-NW-425-520. Localization software for radiotherapy treatment system.
Code Information ISOLOC Software Version 6.0, 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 Andrew D. Jones
425-338-1961
Manufacturer Reason
for Recall		 When ISOLOC version 6.0 software was used in the Anatomic Landmark mode, the couch moves display in the Couch Translator window was incorrect.
FDA Determined
Cause 2		 Software design
Action Software to fix the described problem was written and customers contacted by e-mail on 12/30/2004 that a software patch, titled 12302004 was available to their customers on the firm's internet website.
Quantity in Commerce 79
Distribution Worldwide, including 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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