FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1998-2010
- Recalling firm
- Medtronic Navigation, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2010-05-10
- Posted
- 2010-07-13
- Terminated
- 2011-10-07
- 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 Navigation representative will be contacting you within the coming months to schedule a time to evaluate and service the potentially affected components within your system. A service visit will also be scheduled starting November 2010 to update your system with a software based solution that will prevent this issue from occuring. If you have any questions about this notification, please contact your local Medtronic Navigation representative or call our Technical Services Group at 800-595-9709 or (702) 890-3200.
- 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 India.
- Lot, serial or model codes
- Product Catalog Number: 9732719, 9733346, BI-700-00027-100, BI-70000027-120, BI-700-00027-230
- 510(k) numbers
- ["K050996","K060344"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3004785967
- Firm city
- Littleton
- Firm state
- MA
- Firm country
- not on file
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