FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: ARTIS Pheno VE30A and VE40A, Model 10849000
- Recall number
- Z-1814-2026
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- ARTIS Pheno VE30A and VE40A, Model 10849000
- Status
- Open, Classified
- Initiated
- 2026-03-12
- Posted
- 2026-04-16
- Terminated
- not on file
- Reason
- During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Siemens Medical Solutions USA, Inc. has initiated a Customer Advisory Notice to all affected customers dated March 9, 2026.
- Quantity
- 73
- Distribution
- U.S. and O.U.S.
- Lot, serial or model codes
- UDI 04056869046877
- 510(k) numbers
- ["K230949","K241572"]
- PMA numbers
- not on file
- Product code
- OWB
- 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