FDA Recall
Terminated
PoleStar FlexiCoil band D/E, revisions A and B, Catalog # 9733063, Usage: Low field MRI device used to gather cranial images.
Recall: Z-2240-2010
·
Initiated July 1, 2010
Recall
- Recall Number
- Z-2240-2010
- Event Number
- 56258
- Firm
- Odin Medical Technologies Ltd. Kochav Yokneam 1 Hamelacha St. Yokneam Elit Israel
- FEI Number
- 3003348378
- Product Code
- LNH
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- July 1, 2010
- Posted
- August 19, 2010
- Terminated
- November 9, 2010
Description
PoleStar FlexiCoil band D/E, revisions A and B, Catalog # 9733063, Usage: Low field MRI device used to gather cranial images.
Reason
Electronic box on headstrap may overheat, causing burn to patient.
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.
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.
Quantity
560 units