Class 2 Device Recall PoleStar N20 Magnetic Resonance Diagnostic Device

• Date Initiated by Firm: July 01, 2010
• Date Posted: August 19, 2010
• Recall Status: Terminated 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: 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