104 results
·
64ms
·
Sources: EU EUDAMED, US FDA
ARTIS ZEEGO
FDA Adverse Event
Malfunction
·SIEMENS AG, HEALTHCARE SECTOR·Product code OWB·June 10, 2022
ADVIA CENTAUR HIV AG/AB COMBO (CHIV) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZF·December 10, 2021
ADVIA CENTAUR HIV AG/AB COMBO (CHIV) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZF·December 10, 2021
ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZF·April 13, 2022
ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZF·April 13, 2022
ATELLICA IM HIV AG/AB COMBO (CHIV) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZF·August 23, 2021
ATELLICA IM HIV AG/AB COMBO (CHIV)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZF·July 11, 2025
ADVIA CENTAUR CP HIV AG/AB COMBO (CHIV) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZF·September 25, 2019
ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZF·March 20, 2018
ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZF·March 20, 2018
SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Manufactured by SIEMENS AG, MEDICAL SOLUTIONS, GERMANY.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 13, 2013
ADVIA CENTAUR HIV AG/AB COMBO (CHIV) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZF·November 8, 2021
ADVIA CENTAUR HIV AG/AB COMBO (CHIV) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZF·November 8, 2021
ATELLICA IM HIV AG/AB COMBO (CHIV) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZF·August 23, 2021
SIEMENS brand ONCOR series Linear Accelerator Linac systems with component: any photon unflat beam option(Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. The ARTISTE/ONCOR systems are manufactured by: SIEMENS AG, MEDICAL SOLUTIONS, GERMANY and distributed SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Martinez, CA.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 11, 2013
SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any photon unflat beam option (Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. The ARTISTE/ONCOR systems are manufactured by: SIEMENS AG, MEDICAL SOLUTIONS, GERMANY and distributed SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Martinez, CA
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 11, 2013
SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Manufactured by SIEMENS AG, MEDICAL SOLUTIONS, GERMANY.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·January 17, 2013
ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZF·October 22, 2015
ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZF·October 19, 2018
ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZF·October 19, 2018