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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 Recall
PoleStar N20 Magnetic Resonance Diagnostic Device
see related information
Date Posted August 19, 2010
Recall Status1 Terminated on November 09, 2010
Recall Number Z-2240-2010
Recall Event ID 56258
Premarket Notification
510(K) Number
K032541 
Product Classification System, Nuclear Magnetic Resonance Imaging - 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
Manufacturer Reason
for Recall
Electronic box on headstrap may overheat, causing burn to patient.
FDA Determined
Cause 2
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = ODIN MEDICAL TECHNOLOGIES LTD.
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