FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2240-2010
- Recalling firm
- Odin Medical Technologies Ltd.
- Product
- PoleStar FlexiCoil band D/E, revisions A and B, Catalog # 9733063, Usage: Low field MRI device used to gather cranial images.
- Status
- Terminated
- Initiated
- 2010-07-01
- Posted
- 2010-08-19
- Terminated
- 2010-11-09
- 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.
- Lot, serial or model codes
- No lot numbers or serial numbers.
- 510(k) numbers
- ["K032541"]
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 3003348378
- Firm city
- Elit
- Firm state
- not on file
- Firm country
- Israel
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28