PoleStar FlexiCoil band D/E, revisions A and B, Catalog # 9733063, Usage: Low field MRI device used to gather cranial images.
FDA Recall Z-2240-2010 · Posted 2010-08-19
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Recalling FirmOdin Medical Technologies Ltd.
Recall StatusTerminated
Product CodeLNH
Date Initiated2010-07-01
Date Terminated2010-11-09
Product Quantity560 units
Reason for Recall
Electronic box on headstrap may overheat, causing burn to patient.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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