ARTIS pheno (VE21) System
by Siemens Medical Solutions USA, Inc.
510(k) K220409
ARTIS pheno (VE21) System is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K220409 on 29 Jun 2022, active as of 22 Oct 2026. 2 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
2 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK220409 | Date29 Jun 2022 | StatusActive |
Official records
- FDA 510(k) database K220409
Recalls
-
- Ongoing Z-2361-2023
Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable coming from the generator cabinet and the system may lose the imaging functionality of the corresponding plane and result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system
-
- Ongoing Z-1646-2022
Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown.
Timeline
- Cleared FDA 510(k) K220409
- Recall initiated FDA recalls Z-1646-2022
- Recall initiated FDA recalls Z-2361-2023
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OWB
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1650
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent