PoleStar FlexiCoil band D/E, revisions A and B, Catalog # 9733063, Usage: Low field MRI device used to gather cranial im
FDA device recall Z-2240-2010 · posted 2010-08-19 · Terminated
Recall details
- Recalling firm
- Odin Medical Technologies Ltd.
- Reason for recall
- Electronic box on headstrap may overheat, causing burn to patient.
- Action taken
- 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
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 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, Russ
- Date initiated
- 2010-07-01
- Date posted
- 2010-08-19
- Date terminated
- 2010-11-09
- Location
- Elit, Israel
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| POLESTAR N-20 (K032541) | Odin Medical Technologies , Ltd. | 2003-09-12 |