FDA Medical Device Recalls (openFDA)
Medtronic Navigation, Inc.-Littleton: Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028
- Recall number
- Z-2082-2016
- Recalling firm
- Medtronic Navigation, Inc.-Littleton
- Product
- Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028
- Status
- Terminated
- Initiated
- 2016-03-17
- Posted
- not on file
- Terminated
- 2021-04-06
- Reason
- It has been discovered that replacement x-ray generator and system motion batteries could become damaged during shipment, resulting in unacceptable risk of failure.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Medtronic's planned action to bring device into Compliance. 1. You will provide an Errata sheet to customers updating the missing and incorrect information. 2. Field Service Engineers (FSEs) will perform radiation output measurements via validated procedures to attain compliance with 21CFR part 1020.32(k)(6). 3. You will inspect and test X-ray generator and system motion batteries for damage, in accordance with the plan submitted to CDRH. Damaged batteries will be replaced. 4. You will update the systems software-based instructions for use by a software update which includes the information supplied by the Errata sheet. For further questions, please call (800) 595-9709.
- Quantity
- US - 581
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Model No. BI-700-00027 and BT-700-00028
- 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