Pacific Medical Group Inc. - Class 2 Recall
Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 5, 2020 Category: Medical Devices Source Type: alerts
Pacific Medical Group Inc. - Class 2 Recall
Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 5, 2020 Category: Medical Devices Source Type: alerts
Pacific Medical Group Inc. - Class 2 Recall
Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 5, 2020 Category: Medical Devices Source Type: alerts
Pacific Medical Group Inc. - Class 2 Recall
Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 5, 2020 Category: Medical Devices Source Type: alerts
Koios Medical, Inc. - Koios DS Breast series 1.0 Image Processing System. - Class 2 Recall
Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 18, 2020 Category: Medical Devices Source Type: alerts
Becton Dickinson & Company - SiteRite 8 Ultrasound Systems - Class 2 Recall
Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of the human body. Site~Rite 8 Ultrasound System, Catalog No.9770500 Refurbished, Site~Rite¿ 8 System, Catalog No.9770500R Site~Rite 8 Ultrasound System, Catalog No.9770501 Refurbished Site~Rite¿ 8 System,Catalog No.9770501R Site~Rite 8 Ultrasound System, Catalog No. 9770550 Site~Rite 8 Ultrasound System, Catalog No. 9770552 Site~Rite 8 Ultrasound System, Catalog No. 9770553 Site~Rite 8 Ultrasound System, Catalog No. 9770554 Site~Rite 8 Ultrasound System, Catalog No. 9770555 Site~Rite 8 Ultrasound System Console with Connector, Catalog No.:...
Source: Medical Device Recalls - November 24, 2019 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc. - ACUSON NX3 Diagnostic Ultrasound System - Class 2 Recall
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 ...
Source: Medical Device Recalls - August 23, 2019 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc. - ACUSON NX2 Diagnostic Ultrasound System - Class 2 Recall
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 purpose...
Source: Medical Device Recalls - August 23, 2019 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc. - ACUSON NX3 Diagnostic Ultrasound System - Class 2 Recall
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 th...
Source: Medical Device Recalls - August 23, 2019 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc. - ACUSON NX2 Elite Diagnostic Ultrasound System - Class 2 Recall
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 p...
Source: Medical Device Recalls - August 23, 2019 Category: Medical Devices Source Type: alerts
NeuroLogica Corporation - WS80A Diagnostic Ultrasound System - Class 2 Recall
WS80A Diagnostic Ultrasound System Version 1.00.16, 3.00.17, 3.00.18, 3.00.19, 3.01.00, 3.01.01, 3.01.02, 3.01.03, 3.01.04, 3.01.05, 3.01.06, 3.01.07, 3.01.08, 3.01.09, 4.00.08, 4.00.09, 4.00.10, 4.00.11, 4.01.00, 4.01.01, 4.01.02, 4.01.03, 4.01.04, 4.01.05, 4.01.06, 4.01.07, 4.01.08, 4.01.09. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 15, 2019 Category: Medical Devices Source Type: alerts
NeuroLogica Corporation - HS70A Diagnostic Ultrasound System - Class 2 Recall
HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03, 2.01.04, 2.01.05, 2.01.06, 1.00.06, 1.00.07, 1.00.08, 1.00.09, 1.00.10, 1.00.11, 1.00.12 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 15, 2019 Category: Medical Devices Source Type: alerts
Philips Ultrasound Inc - Philips EPIQ and Affiniti Ultrasound Systems - Class 2 Recall
Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ CVx, Affiniti 30, Affiniti 50, and Affiniti 70. Product Usage: The intended use of the EPIQ, EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperat...
Source: Medical Device Recalls - August 7, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Ultrasound Probe RIC59D - Class 2 Recall
Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 13, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Vscan Extend - Class 2 Recall
LVivo EF app on Vscan Extend. Sold under the following product names: a. Vscan Extend Dual DICOM, Model Numbers H41212ZA, H41212RN; b .Vscan Extend Dual USB, Model Number H41212RK; c. Vscan Extend Dual Wi-Fi, Model Numbers H41212YZ, H41212RL; d. Vscan Extend Sector DICOM, Model Number H41212ZD; e. Vscan Extend Sector USB, Model Number H41212RR; f. Vscan Extend Sector Wi-Fi, Model Number H41212ZC Product Usage: Vscan Extend is a general- purpose diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and flui...
Source: Medical Device Recalls - June 19, 2019 Category: Medical Devices Source Type: alerts
