FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Arcadis Orbic Mobile X-Ray System
- Recall number
- Z-0438-06
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Arcadis Orbic Mobile X-Ray System
- Status
- Terminated
- Initiated
- 2005-12-12
- Posted
- 2006-01-25
- Terminated
- 2008-09-04
- Reason
- patient information can be stored in another patient's file.
- Root cause
- Other
- Action
- The recalling firm has issued a Customer Safety Advisory to the affected customers per Update Instructions SP030/05/S. The letter informs customers of the potential problem and provides a suggestion to avoid this issue.
- Quantity
- 179 units
- Distribution
- The product was shipped to medical facilities nationwide.
- Lot, serial or model codes
- model number 8081080
- 510(k) numbers
- ["K042793"]
- PMA numbers
- not on file
- Product code
- JAK
- 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