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U.S. Department of Health and Human Services

Class 2 Device Recall PoleStar N20 Magnetic Resonance Diagnostic Device

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  Class 2 Device Recall PoleStar N20 Magnetic Resonance Diagnostic Device see related information
Date Initiated by Firm July 01, 2010
Date Posted August 19, 2010
Recall Status1 Terminated 3 on November 09, 2010
Recall Number Z-2240-2010
Recall Event ID 56258
510(K)Number K032541  
Product Classification Magnetic Resonance Diagnostic Device - Product Code LNH
Product PoleStar FlexiCoil band D/E, revisions A and B, Catalog # 9733063,

Usage: Low field MRI device used to gather cranial images.
Code Information No lot numbers or serial numbers.
Recalling Firm/
Manufacturer		 Odin Medical Technologies Ltd.
Kochav Yokneam
1 Hamelacha St.
Yokneam Elit Israel
For Additional Information Contact
720-890-3217
Manufacturer Reason
for Recall		 Electronic box on headstrap may overheat, causing burn to patient.
FDA Determined
Cause 2		 Device Design
Action Customers were notified by letter on 07/07/2010, advising them of the overheating problem and alerting them that a service rep will be visiting to inspect and upgrade any affected FlexiCoils. Questions were referred to 800-595-9709.
Quantity in Commerce 560 units
Distribution CA, CO, DC, IL, IN, MD, MI, MN, MO, NE, NJ, NV, NY, OH, OR, WA, and WI. Foreign distribution to Austria, Belgium, Canada, China, France, Germany, Israel, Italy, Korea, Netherlands, Poland, Spain, Russia, Switzerland and Turkey.
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 = LNH and Original Applicant = ODIN MEDICAL TECHNOLOGIES LTD.
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