Recall Z-1998-2010 ยท LLZ System, Image Processing, Radiological
Medtronic Navigation, Inc.
O-Arm Imaging System The O-Arm imaging system is a mobile X-Ray system designed for medical applications in surgical theaters, focusing on 3D imaging but also offering 2D fluoroscopic Imaging.
| Date | Jul 13, 2010 (initiated May 10, 2010) |
| Status | Terminated |
| Reason | The possibility that the real time image display can freeze up during use of a 2D continuous fluoroscopy. |
| Root cause | Device Design |
| Action | The firm, Medtronic, Inc., sent an "Urgent Field Safety Notice" letter dated May 10, 2010, to all custmers. The letter describes the product, problem and actions to be taken by customer. The firm recommended that the users of the O-Arm Imaging System reveiw the information provided to ensure patient safety remains uncompromised during use of the product. The customers were instructed to discontinue use and contact your local Medtronic Navigation representative or call our Technical Services Group at 800-595-9709 or (702) 890-3200, if the image is not updating as expected. A Medtronic Navigati |
| Quantity | 221 |
| Distribution | Worldwide distribution: USA and countries of Germany, Singapore, South Africa, Poland, Libya, Belgium, Switzerland, Turkey, Italy, Denmark, France, Spain, Finland, Czech Republic, Ireland, Slovakia, the NetherLands, Austria, UAE, Kuwait, Israel, Australia, Sweden, Canada, South Korea, Japan and Ind |
| FDA record | Open on fda.gov |