Recall Z-2240-2010 ยท LNH System, Nuclear Magnetic Resonance Imaging
Odin Medical Technologies Ltd.
PoleStar FlexiCoil band D/E, revisions A and B, Catalog # 9733063, Usage: Low field MRI device used to gather cranial images.
| Date | Aug 19, 2010 (initiated Jul 1, 2010) |
| Status | Terminated |
| Reason | Electronic box on headstrap may overheat, causing burn to patient. |
| Root 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032541 | POLESTAR N-20 Odin Medical Technologies , Ltd., Sep 12, 2003 |