Olympus Corporation of the Americas - Ultrasound Gastroscopes, Gastroscopes, Colonoscopes and Duodenoscopes - Class 2 Recall
Olympus GIF-H180J Gastrointestinal Videoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 13, 2019 Category: Medical Devices Source Type: alerts
Olympus Corporation of the Americas - Ultrasound Gastroscopes, Gastroscopes, Colonoscopes and Duodenoscopes - Class 2 Recall
Olympus TJF-Q180V Duodenoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 13, 2019 Category: Medical Devices Source Type: alerts
Olympus Corporation of the Americas - Ultrasound Gastroscopes, Gastroscopes, Colonoscopes and Duodenoscopes - Class 2 Recall
Olympus GF-UCT180 Ultrasound Gastrovideoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 13, 2019 Category: Medical Devices Source Type: alerts
Olympus Corporation of the Americas - Ultrasound Gastroscopes, Gastroscopes, Colonoscopes and Duodenoscopes - Class 2 Recall
Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 13, 2019 Category: Medical Devices Source Type: alerts
Abbott Vascular - Plus 30 PRIORITY PACK (Accessories Kits) - Class 2 Recall
PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices). (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 27, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - GE HEALTHCARE LOGIQ P6 Premium - Class 2 Recall
GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09 (b) Model BT07 Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric). Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, vascular). (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 31, 2019 Category: Medical Devices Source Type: alerts
Volcano Corporation - Visions PV .035 Digital IVUS Catheter - Class 2 Recall
Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0200.173 Product Usage: The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultrasound transducer on the distal tip. The transducer utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels. The devices are provided sterile and are single use disposable devices. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 12, 2019 Category: Medical Devices Source Type: alerts
Volcano Corporation - Visions PV .035 Digital IVUS Catheter - Class 2 Recall
Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0200.272 Product Usage: The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultrasound transducer on the distal tip. The transducer utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels. The devices are provided sterile and are single use disposable devices. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 12, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - GE LOGIQ E10 Ultrasound System - Class 2 Recall
GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculoskeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (vascular). (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 8, 2018 Category: Medical Devices Source Type: alerts
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL - GE Vivid E95 ultrasound system - Class 2 Recall
GE Vivid E95 ultrasound system Product The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular). (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 7, 2018 Category: Medical Devices Source Type: alerts
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL - GE Vivid E9 ultrasound system - Class 2 Recall
GE Vivid E9 ultrasound system Product Usage: GE Vivid E9 ultrasound system is a general purpose ultrasound system for use in cardiac imaging. It is intended for use by, or under direction of a qualified physician for ultrasound imaging and analysis of Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, Testes, thyroid; Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate) Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, Thoracic, & vascular) (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 7, 2018 Category: Medical Devices Source Type: alerts
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL - GE Vivid E80 ultrasound system - Class 2 Recall
GE Vivid E80 ultrasound system Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of fetal/Obstetrics; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and lntraoperative (abdominal, thoracic, & va...
Source: Medical Device Recalls - September 7, 2018 Category: Medical Devices Source Type: alerts
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL - GE LOGIQ E9 ultrasound system - Class 2 Recall
GE LOGIQ E9 ultrasound system Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic and vascular). (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 7, 2018 Category: Medical Devices Source Type: alerts
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL - GE LOGIQ 9 ultrasound system - Class 2 Recall
GE LOGIQ 9 ultrasound system Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic and vascular). (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 7, 2018 Category: Medical Devices Source Type: alerts
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL - GE Vivid E90 ultrasound system - Class 2 Recall
GE Vivid E90 ultrasound system Product Usage: Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of fetal/Obstetrics; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and lntraoperative (abdominal, thoraci...
Source: Medical Device Recalls - September 7, 2018 Category: Medical Devices Source Type: alerts
