Boston Scientific Corporation - AURIGA 30 GENERAL SYSTEM - Class 2 Recall
AURIGA 30 GENERAL SYSTEM UPN: M0068S30G0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 23, 2019 Category: Medical Devices Source Type: alerts
Boston Scientific Corporation - AURIGA 30 BRAZIL SYSTEM - Class 2 Recall
AURIGA 30 BRAZIL SYSTEM UPN: M0068S30B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 23, 2019 Category: Medical Devices Source Type: alerts
Boston Scientific Corporation - AURIGA XL 4007 BRAZIL SYSTEM - Class 2 Recall
AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 23, 2019 Category: Medical Devices Source Type: alerts
Fetzer Medical GmbH & Co. KG - De Lee Obstetric Forceps - Class 2 Recall
16600 / Fetzer Surgical De Lee Obstetric Forceps, 11" (30cm), Item No./Product Code 46-5034 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to facilitate its passage through the birth canal. The instruments are only used for female population. The product is non-powder, non-liquid, non-tablet, capsule or other. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 19, 2019 Category: Medical Devices Source Type: alerts
Fetzer Medical GmbH & Co. KG - Simpson Obstetric Forceps - Class 2 Recall
12002 / Boss Instruments Simpson OB Forceps, short model, 13" (33cm), Item No./Product Code 46-5040 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to facilitate its passage through the birth canal. The instruments are only used for female population. The product is non-powder, non-liquid, non-tablet, capsule or other. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 19, 2019 Category: Medical Devices Source Type: alerts
Fetzer Medical GmbH & Co. KG - Wrigley Obstetric Forceps - Class 2 Recall
12002 / Boss Instruments Ltd. Wrigley Obstetric Forceps, 11" (28cm), Item No./Product Code 46-5004 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to facilitate its passage through the birth canal. The instruments are only used for female population. The product is non-powder, non-liquid, non-tablet, capsule or other. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 19, 2019 Category: Medical Devices Source Type: alerts
Fetzer Medical GmbH & Co. KG - Luikart Simpson Obstetrical Forceps - Class 2 Recall
16600 / Fetzer Surgical Luikart Simpson OB Forceps14" (35.5cm), Item No./Product Code 46-5050 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to facilitate its passage through the birth canal. The instruments are only used for female population. The product is non-powder, non-liquid, non-tablet, capsule or other. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 19, 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
AS Software, Inc. - ASOBGYN Information System version 7.824.x - Class 2 Recall
AS-OBGYN Information System version 7.824.x (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 17, 2018 Category: Medical Devices Source Type: alerts
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL - GE Vivid E7 ultrasound system - Class 2 Recall
GE Vivid E7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound system, 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; Musculo-skeletal Superficial; Urology (including prostate); Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic...
Source: Medical Device Recalls - September 7, 2018 Category: Medical Devices Source Type: alerts
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL - GE Vivid 7 ultrasound system - Class 2 Recall
GE Vivid 7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound system, 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; Musculo-skeletal Superficial; Urology (including prostate); Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic,...
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
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
CooperSurgical, Inc. - 2 MHZ Waterproof OB Probe - Class 2 Recall
Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz Waterproof OB probe is for obstetrical use in the labor and department for late term obstetrical examination associated with larger women. The product detects fetal heart beats as an aid for determining fetal viability. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 20, 2018 Category: Medical Devices Source Type: alerts
Avid Medical, Inc. - AVID TruCustom - Class 2 Recall
AVID TruCustom OBSTETRICAL PACK convenience kits, Item Code: HLDH008-04 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 1, 2018 Category: Medical Devices Source Type: alerts
