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    ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869050775 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc.·Product code IYN·January 28, 2019

    ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869030005 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc.·Product code IYN·January 28, 2019

    Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code JHX·March 31, 2025

    ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B; UDI # 04056869004303 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc.·Product code IYN·January 28, 2019

    ACUSON NX3 Diagnostic Ultrasound System, Model # 11235612, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B; UDI # 04056869004297 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc.·Product code IYN·January 28, 2019

    Atellica IM Erythropoietin (EPO) Assay (100 Test)

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code GGT·January 24, 2024

    ADVIA Centaur Erythropoietin (EPO) Assay (100 Test)

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code GGT·January 24, 2024

    Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327700

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·February 25, 2022

    Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·February 25, 2022

    Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use-single and biplane diagnostic imaging and interventional procedures. Model: 10849000

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·February 25, 2022

    Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JJE·May 7, 2020

    Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JJE·May 7, 2020

    Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·April 11, 2022

    Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·April 11, 2022

    Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code PDJ·February 9, 2022

    Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code NDW·February 9, 2022

    Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CJY·February 9, 2022

    Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code LCP·February 9, 2022

    Atellica CH 2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of 2-microglobulin in human serum and plasma. Siemens Material Number (SMN): 11097635

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JZG·October 21, 2024

    Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JGS·May 4, 2021