FDA Medical Device Recalls (openFDA)
Medtronic Navigation, Inc.: BI-700-00027 0-arm 1000 Imaging System Mobile X-ray System Generating 2D and 3D images of human anatomy for surgical applications.
- Recall number
- Z-2034-2008
- Recalling firm
- Medtronic Navigation, Inc.
- Product
- BI-700-00027 0-arm 1000 Imaging System Mobile X-ray System Generating 2D and 3D images of human anatomy for surgical applications.
- Status
- Terminated
- Initiated
- 2008-06-30
- Posted
- 2008-09-26
- Terminated
- 2008-12-04
- Reason
- Failure to of affected units to comply with EER/AKR limits due to misinterpretation of the measurement requirements specified in 21 CFR 1020.32 (d) (3) (iii)
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Medtronic Navigation notified service engineers to retest units for compliance.
- Quantity
- 10 units
- Distribution
- CA, DC, LA, FL. IN, OH, PA, VA
- Lot, serial or model codes
- S/N: 102, 125, 127, 129, 130, 134, 137, 147, 157, and 159.
- 510(k) numbers
- ["K050996"]
- PMA numbers
- not on file
- Product code
- JAA
- 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