FDA Medical Device Recalls (openFDA)
Medtronic Navigation, Inc.: Medtronic O-arm Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.
- Recall number
- Z-2244-2012
- Recalling firm
- Medtronic Navigation, Inc.
- Product
- Medtronic O-arm Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.
- Status
- Terminated
- Initiated
- 2012-07-11
- Posted
- 2012-08-22
- Terminated
- 2016-06-06
- Reason
- A fault in a high voltage relay in the 0-arm Imaging System might cause the relay to overheat and burn.
- Root cause
- Component change control
- Action
- Medtronic Navigation issued an "Urgent Field Safety Notice" to consignees dated 7/11/12. The problem was described and recommended actions were provided. For each affected O-arm Imaging System, a Medtronic service representative will visit the site and replace the 500VDC relay on the system and test the O-arm Imaging System.
- Quantity
- 17 units
- Distribution
- Worldwide Distribution - USA, including the states of AL, CO, FL, IA, MI, IA, NC, NE, NY and the countries of South Africa, Italy, and Spain.
- Lot, serial or model codes
- Serial Numbers: 109R, 118R, 124, 136, 159 ,170, 218, 222, 223, 236, 239 , 299, 309R, 402, 410, 412, 414.
- 510(k) numbers
- ["K092564"]
- PMA numbers
- not on file
- Product code
- OXO
- 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