FDA Medical Device Recalls (openFDA)
SIEMENS MEDICAL SOLUTIONS USA, INC: ARTIS One Angiographic X-Ray System
- Recall number
- Z-0922-2025
- Recalling firm
- SIEMENS MEDICAL SOLUTIONS USA, INC
- Product
- ARTIS One Angiographic X-Ray System
- Status
- Open, Classified
- Initiated
- 2025-01-02
- Posted
- 2025-01-29
- Terminated
- not on file
- Reason
- A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose-rate may be higher than intended by the user.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- not on file
- Quantity
- 1140
- Distribution
- 23 Distributed in the US
- Lot, serial or model codes
- Model Number 10848600
- 510(k) numbers
- ["K133580"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 3016408824
- Firm city
- Malvern
- Firm state
- not on file
- Firm country
- Germany
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