Z-2240-2010

PoleStar FlexiCoil band D/E, revisions A and B, Catalog # 9733063, Usage: Low field MRI device used to gather...

Name: Z-2240-2010 PoleStar FlexiCoil band D/E, revisions A and B, Catalog # 9733063, Usage: Low field MRI device used to gather...
Creator: Odin Medical Technologies Ltd.
Published: 2010-07-01
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2010-07-01 / Terminated / root cause: design

FDA source

Odin Medical Technologies Ltd. began a recall of PoleStar FlexiCoil band D/E, revisions A and B, Catalog # 9733063, Usage: Low field MRI device used to gather cranial images on 2010-07-01. The reason FDA records is "Electronic box on headstrap may overheat, causing burn to patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2240-2010
Status: Terminated
Initiated: 2010-07-01
Posted: 2010-08-19
Terminated: 2010-11-09
Recalling firm: Medtronic Navigation, Inc
Product: PoleStar FlexiCoil band D/E, revisions A and B, Catalog # 9733063, Usage: Low field MRI device used to gather cranial images.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Electronic box on headstrap may overheat, causing burn to patient.
Root cause tag: design
FDA 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 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.
Product codes and lots: No lot numbers or serial numbers.

Product code LNH

K032541Class IIPolestar N-20Odin Medical Technologies , Ltd. / cleared 2003-09-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)