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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 28, 2005
Date Posted August 08, 2007
Recall Status1 Terminated 3 on April 20, 2011
Recall Number Z-1152-2007
Recall Event ID 38360
510(K)Number K904908  
Product Classification radiotherapy treatment software - Product Code IYE
Product ISOLOC Software Versions 6.0 and 4.2. Part Number NT-NW-425-520. Image guided radiotherapy treatment software.
Code Information ISOLOC Software Versions 6.0 & 4.2 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 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.
FDA Determined
Cause 2		 Software design
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.
Quantity in Commerce 84
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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