FDA Medical Device Recalls (openFDA)
Medtronic Navigation, Inc.-Littleton: Medtronic Navigation O-arm 02 surgical x-ray imaging system
- Recall number
- Z-2083-2016
- Recalling firm
- Medtronic Navigation, Inc.-Littleton
- Product
- Medtronic Navigation O-arm 02 surgical x-ray imaging system
- Status
- Terminated
- Initiated
- 2016-03-17
- Posted
- not on file
- Terminated
- 2021-04-06
- Reason
- Review of on-system electronic product labeling and Instr uctions for Use in response to an internal management concern uncovered gaps in compliance with the requirements for information to be provided to users in 21CFR part 1 020.30(h).
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Medtronic planned action to bring device into Compliance: 1. You will contact customers and provide an Errata sheet to them updating the missing and incorrect information. 2. Medtronic field service personnel will perform radiation output measurements via validated procedures to attain compliance with 21CRF part 1020.32(k)(6). 3. You will update the systems software-based instructions for use by a software update which includes the information supplied by the Errata sheet. For questions call (800)-595-9709.
- Quantity
- US - 63
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- model number BT-700-02000
- 510(k) numbers
- ["K151000"]
- PMA numbers
- not on file
- Product code
- OWB
- 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