83 results
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59ms
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Sources: EU EUDAMED, US FDA
CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM
FDA Adverse Event
Malfunction
·STERILMED, INC.·Product code OWQ·May 5, 2023
ACUSON S2000 ULTRASOUND SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code IYO·March 10, 2017
ACUSON ACUNAV¿ ULTRASOUND CATHETER
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code OBJ·March 10, 2017
ACUSON SEQUOIA C512 ULTRASOUND SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code IYN·December 1, 2017
SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code OBJ·December 30, 2020
ACUSON ACUNAV 8F-90 ULTRASOUND CATHETER
FDA Adverse Event
Injury
·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code OBJ·December 4, 2017
NA
FDA Adverse Event
Malfunction
·STERILMED, INC.·Product code OWQ·August 29, 2024
NA
FDA Adverse Event
Malfunction
·STERILMED, INC.·Product code OWQ·August 14, 2025
NA
FDA Adverse Event
Malfunction
·STERILMED, INC.·Product code OWQ·August 15, 2025
NA
FDA Adverse Event
Malfunction
·STERILMED, INC.·Product code OWQ·August 14, 2025
NA
FDA Adverse Event
Malfunction
·STERILMED, INC.·Product code OWQ·August 14, 2025
NA
FDA Adverse Event
Malfunction
·STERILMED, INC.·Product code OWQ·August 15, 2025
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014
ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·May 16, 2018
NA
FDA Adverse Event
Malfunction
·STERILMED, INC.·Product code OWQ·August 15, 2025
ACUSON Sequoia Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system. Siemens Medical Solutions USA, Inc., Mountain View, CA
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYN·September 25, 2007
ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical Solutions USA Inc. business Unit: Ultrasound. The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging of the breast allows volumetric acquisition of the breast image.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·March 20, 2013
Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc. Mountain View, CA 94043 Medical Device for human use. Ultrasound imaging system used to measure anatomical structures and calculation packages that provide information to the clinician for clinical diagnosis purposes.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·October 30, 2013
ACUSON SC2000 Power Input: 100-240VAC, 1600 Max 50/60Hz; Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 Ultrasound imaging system.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·February 5, 2014
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYN·June 3, 2014