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Sources: EU EUDAMED, US FDA
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BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethylene Oxide Gas, Prescription Only, Manufacturer BridgePoint Medical Inc. 13355 10th Ave N, Suite 110, Plymouth, MN 55441. Stingray" Catheters are intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions) prior to PTCA or stent intervention. When used as part of the BridgePoint Medical System, the Stingray Catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions [CTOs]) prior to PTCA or stent intervention. .
FDA Enforcement
Class II
·Terminated·Bridgepoint Medical·August 1, 2012
Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distributed by Ethicon Ethicon Inc., Somerville, NJ 08876 USA Manufactured by Ferrosan Medical Devices Ferrosan Medical Devices A/S Sydmarken 5, DK-2860 Soeberg, Denmark Mixed with sterile saline or thrombin solution is indicated for surgical procedures (except opthalmic) for hemostasis when control of capillary, venous and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical.
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 4, 2012
ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc. Somerville, NJ 08876 USA Ref 2993 SURGIFLO Hemostatic Matrix, mixed with sterile saline or thrombin solution, is indicated for surgical procedures (except ophthalmic) for hemostasis, when control of capillary, venous and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical. This is a topical absorbable hemostat consisting of a flowable gelatin matrix (paste) and a lyophilized Thrombin component. This kit also contains components necessary for preparing and applying the matrix during surgery.
FDA Enforcement
Class I
·Terminated·Ethicon, Inc.·November 28, 2012
ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc. Somerville, NJ 08876, USA SURGIFLO Hemostatic Matrix is a topical absorbable hemostat consisting of a flowable gelatin matrix (paste). This kit also contains components necessary for preparing and applying the matrix during surgery. SURGIFLO Hemostatic Matrix, mixed with sterile saline or thrombin solution, is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical.
FDA Enforcement
Class I
·Terminated·Ethicon, Inc.·November 28, 2012
BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethylene Oxide Gas, Prescription Only, Manufacturer BridgePoint Medical Inc. 13355 10th Ave N, Suite 110, Plymouth, MN 55441. Stingray" Catheters are intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions) prior to PTCA or stent intervention. When used as part of the BridgePoint Medical System, the Stingray Catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions [CTOs]) prior to PTCA or stent intervention. .
FDA Recall
Terminated
·Bridgepoint Medical·Product code DQY·June 26, 2012
MPI Rapid Response HUT Table, Model #RRHUT 1017. The firm name on the label is Medical Positioning Inc., Kansas City, MO. Designed for multiple uses including a conventional examination table, unexplained syncope, neurocardiogenic syncope, chronic fatigue syndrome, and most noninvasive procedures.
FDA Recall
Terminated
·Medical Positioning Inc·Product code LGX·March 5, 2012
ACUSON SC2000 Ultrasound System; Power Input: 100-240VAC, 1600W Max, 50/60 Hz. Manufacturer: Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 SC2000 ultrasound imaging system is intended for Cardiac, neo-natal and fetal cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal interoperative, Intraoperative Neurological, Musculo-skeletal Conventional and musculo-skeletal Superficial Applications. The system also provided the ability to measure anatomical structures and calculation packages that provide information to the clinician that my be used adjunctively and with other medical data obtained by a physician for clinical diagnosis purposes.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·February 5, 2014
Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distributed by Ethicon Ethicon Inc., Somerville, NJ 08876 USA Manufactured by Ferrosan Medical Devices Ferrosan Medical Devices A/S Sydmarken 5, DK-2860 Soeberg, Denmark Mixed with sterile saline or thrombin solution is indicated for surgical procedures (except opthalmic) for hemostasis when control of capillary, venous and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical.
FDA Recall
Terminated
·Ethicon, Inc. US·Product code LMF·April 3, 2012
MPI Rapid Response HUT Table, Model #RRHUT 1217 with Dual 2 Way Drop Section. The firm name on the label is Medical Positioning Inc., Kansas City, MO. Designed for multiple uses including a conventional examination table, unexplained syncope, neurocardiogenic syncope, chronic fatigue syndrome, and most noninvasive procedures. With the optional drop section, the use expands to echo/stress echo/Doppler studies, and vascular and carotid echo.
FDA Recall
Terminated
·Medical Positioning Inc·Product code LGX·March 5, 2012
Varian brand Clinac, Medical Linear Accelerator, All Varian Clinac with Model Numbers: H14, H18, H26, H27, H28, H29, Hcx; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Trilogy Radiotherapy Delivery System is a radiation therapy accelerator intended to deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactic treatments are intended for therapy of lesions, e.g., arteriovenous malformations, primary tumors and metastases.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·March 28, 2011
Siemens brand ACUSON S2000 Ultrasound System with software versions: VA10, VA10A, VA10B, VA10C, VA15; Model Number: 10041461; Product is manufactured and distributed by Siemens Medical Solutions USA, Inc. Ultrasound Business Unit, Mountain View, CA The ACUSON SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code GKZ·January 14, 2009
Clinac High Energy Medical Linear Accelerator, a Trilogy Radiotherapy Delivery System; Model #s: H14, H18, H27, H29, HCX; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Trilogy Radiotherapy Delivery System is a radiation therapy accelerator intended to deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactic treatments are intended for therapy of lesions, e.g., arteriovenous malformations, primary tumors and metastases. Stereotactic treatments may be intracranial or extra cranial and consist of single-session or fractionated delivery.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·February 24, 2011
FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations.
FDA Recall
Terminated
·Fujifilm Medical Systems U.S.A., Inc.·Product code KPR·June 15, 2017
ACUSON SC 2000 ultrasound system. Siemens Medical Solutions USA, Inc. Business Unit Ultrasound 1230 Shorebird Way Mountain View, CA 94043 Intended use: SC2000 ultrasound system is intended for the following applications: Cardiac, neo-Natal and fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skeletal Conventional, and anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medial data obtained by a physician for clinical diagnosis purposes.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYN·September 29, 2010
ACUSON SC2000 Ultrasound System; Power Input: 100-240VAC, 1600W Max, 50/60 Hz. Manufacturer: Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 SC2000 ultrasound imaging system is intended for Cardiac, neo-natal and fetal cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal interoperative, Intraoperative Neurological, Musculo-skeletal Conventional and musculo-skeletal Superficial Applications. The system also provided the ability to measure anatomical structures and calculation packages that provide information to the clinician that my be used adjunctively and with other medical data obtained by a physician for clinical diagnosis purposes.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYN·December 22, 2013
ACUSON Sequoia 12.X GI Base System, model number 10042701. Distributed by Siemens Medical Solutions USA, Inc., Business Unit Ultrasound, Mountain View, CA. The ACUSON Sequoia is a general purpose Diagnostic Ultrasound system. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in: B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, Harmonic Imaging or 3D imaging on a FPD Display. The ACUSON Sequoia is intended for the following applications: Abdominal, General Imaging and Cardiolgoy for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breat, testes, thyroid and penis), Neonatal/Adult Cephalic, Cardiac (adult, pediatric and neonatal), Transesophageal, Transrectal, Transvaginal, Peripheral Vessels and Musculo-sceletal (superficial and conventional) applications. The system also provides for the measurement of anatomical structures that provide information that is used for clinical diagnosis purposes.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYN·May 15, 2009
ACUSON Sequoia C512/512SS Adv PE 10.0 System, model number 10041127. Distributed by Siemens Medical Solutions USA, Inc., Business Unit Ultrasound, Mountain View, CA. The ACUSON Sequoia is a general purpose Diagnostic Ultrasound system. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in: B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, Harmonic Imaging or 3D imaging on a FPD Display. The ACUSON Sequoia is intended for the following applications: Abdominal, General Imaging and Cardiolgoy for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breat, testes, thyroid and penis), Neonatal/Adult Cephalic, Cardiac (adult, pediatric and neonatal), Transesophageal, Transrectal, Transvaginal, Peripheral Vessels and Musculo-sceletal (superficial and conventional) applications. The system also provides for the measurement of anatomical structures that provide information that is used for clinical diagnosis purposes.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYN·May 15, 2009
ACUSON Sequoia 12.X C512/512 SS Base System, model number 10042700. Distributed by Siemens Medical Solutions USA, Inc., Business Unit Ultrasound, Mountain View, CA. The ACUSON Sequoia is a general purpose Diagnostic Ultrasound system. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in: B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, Harmonic Imaging or 3D imaging on a FPD Display. The ACUSON Sequoia is intended for the following applications: Abdominal, General Imaging and Cardiolgoy for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breat, testes, thyroid and penis), Neonatal/Adult Cephalic, Cardiac (adult, pediatric and neonatal), Transesophageal, Transrectal, Transvaginal, Peripheral Vessels and Musculo-sceletal (superficial and conventional) applications. The system also provides for the measurement of anatomical structures that provide information that is used for clinical diagnosis purposes.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYN·May 15, 2009
Varian brand C-series Clinac, Trilogy and Novalis Tx, Software Versions 6.X and 7.X, Model Numbers: H14, H27, H29, HCX, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Trilogy Radiotherapy Delivery System is a radiation therapy accelerator intended to deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactic treatments are intended for therapy of lesions, e.g., arteriovenous malformations, primary tumors and metastases. Stereotactic treatments may be intracranial or extra cranial and consist of single-session or fractionated delivery.
FDA Recall
Terminated
·Varian Medical Systems Oncology Systems·Product code GKZ·June 10, 2010
Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI board 10434200; The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYN·March 28, 2013