FDA Medical Device Recalls (openFDA)
Medtronic Navigation, Inc.-Boxborough: O-arm O2 Imaging System. Mobile X-Ray System.
- Recall number
- Z-2101-2025
- Recalling firm
- Medtronic Navigation, Inc.-Boxborough
- Product
- O-arm O2 Imaging System. Mobile X-Ray System.
- Status
- Open, Classified
- Initiated
- 2025-05-27
- Posted
- 2025-07-09
- Terminated
- not on file
- Reason
- A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
- Root cause
- Under Investigation by firm
- Action
- An URGENT: MEDICAL DEVICE CORRECTION notice dated 5/27/25 was mailed to consignees. In the notice consignees are instructed to discontinue use of affected systems until it can be serviced by Medtronic personnel; a copy of the recall notification is to be posted with the system until the issue has been resolved. A Medtronic Field Service Engineer will contact consignees to schedule a visit to inspect affected systems and implement any corrections needed. Consignees are to complete and return the provided Customer Confirmation Form and forward the recall notification to all users and facilities to which product was further distributed. Consignees with any questions can contact Technical Services for help by phone at 1-888-826-5603 or by email at rs.navtechsupport@medtronic.com.
- Quantity
- 3 units
- Distribution
- US Nationwide distribution in the states of IN, MN, MS.
- Lot, serial or model codes
- CFN: BI70002000; UDI: 00763000709631; Serial No. C4014, C4017, C4019.
- 510(k) numbers
- ["K240465"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 3004785967
- Firm city
- Boxborough
- 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