FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: 3D-I/III Ceiling Stand. Diagnostic x-ray tube mount
- Recall number
- Z-1205-06
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- 3D-I/III Ceiling Stand. Diagnostic x-ray tube mount
- Status
- Terminated
- Initiated
- 2006-04-28
- Posted
- 2006-07-06
- Terminated
- 2008-09-30
- Reason
- Firm became aware that a potential pinch point can exist between the stop level and the safety catch when rotating the x-ray tube assembly. Risk of injury to operators fingers.
- Root cause
- Other
- Action
- The recalling firm has issued a field correction per Update Instructions AX012/06/S. This update instructs a Siemens Customer Service Engineer to visit affected consignees to install a protective cover and additional warning labels on the device, beginning 04/28/2006.
- Quantity
- 466 units
- Distribution
- The products were shipped nationwide to medical facilities.
- Lot, serial or model codes
- Model numbers 0923/G0923, 1022, 1080, 1212687, 1371970, 1372325, 1654250, 1576164, 8186751, 7388002, 7389489, 1738509, 1738517, 1738525, 7276504, 7276512, 7276520, 7276553, 7465008, 7486822, and 8185530.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IYB
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- 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