FDA Medical Device Recalls (openFDA)
Xoran Technologies, Inc.: Xoran MiniCAT CT Scanner ID ENT00001
- Recall number
- Z-0041-2014
- Recalling firm
- Xoran Technologies, Inc.
- Product
- Xoran MiniCAT CT Scanner ID ENT00001
- Status
- Terminated
- Initiated
- 2009-12-14
- Posted
- not on file
- Terminated
- 2014-09-11
- Reason
- Failure of the gantry to rotate. The complaint alleged that the scanner would emit radiation but would not rotate.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- The service report in response to this complaint stated that the Head select relay board, chip and fan were replaced. The machine (ENTOOOO I) was subsequently tested. All tests were successful.
- Quantity
- 320
- Distribution
- Worldwide Distribution - US nationwide
- Lot, serial or model codes
- minicat
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 3004198450
- Firm city
- Ann Arbor
- Firm state
- MI
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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