| Class 2 Device Recall PoleStar N20 Magnetic Resonance Diagnostic Device | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = LNH
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