Dornier Medtech America, Inc. - Class 2 Recall
Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Number/Description: K1001291 600 micron single use fiber K2011824 600 micron single use fiber K1001293 600 micron single use fiber K2011826 600 micron 5X reusable fiber K1008084 600 micron single use fiber K2011828 400 micron 5X reusable fiber K1010500 600 micron fibertome fiber K2012021 600 micron single use fiber K1015640 AngioSpot Fiber Kit K2012393 600 micron single use fiber K2010292 400 micron single use fiber K2012439 600 micron 5X reusable fiber K2010667 micron ITT fiber K2012875 600 micron 3X reusable fiber K2010710 400 micron single use fib...
Source: Medical Device Recalls - May 22, 2019 Category: Medical Devices Source Type: alerts
Integra Limited - Integra Flowable Wound Matrix - Class 2 Recall
Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the treatment of tunneling and/or undermined wounds including: surgical wounds (donor sites/grafts, post-Moh s surgery, post-laser surgery, podiatric, wound dehiscence) and diabetic ulcers of both partial and full-thickness varieties. The device is intended for one-time use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 16, 2019 Category: Medical Devices Source Type: alerts
Johnson & Johnson Surgical Vision Inc - OptiMedca Catalys Precision Laser System - Class 2 Recall
OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states "Manufactured for: OptiMedica Corporation 1310 Moffett Park Drive Sunnyvale, CA 94089 USA Product Label for Serial Numbers: 46120916; 46123116, 46124617; 46131418, and 46131618 label states "Manufactured for: OptiMedica Corporation 510 Cottonwood Drive Milpitas, CA 95035 USA The Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery ...
Source: Medical Device Recalls - October 4, 2018 Category: Medical Devices Source Type: alerts
Medtronic Navigation, Inc. - Visualase Cooled Laser Applicator System - Class 2 Recall
Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Number 9735559, Visualase¿ Cooled Laser Applicator System 3mm Tip; b. Part Number 9735560 Visualase¿ Cooled Laser Applicator System 10mm Tip; c. Part Number 9735561 Visualase¿ Cooled Laser Applicator System 15mm Tip Product Usage: The Visualase Thermal Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial...
Source: Medical Device Recalls - July 20, 2018 Category: Medical Devices Source Type: alerts
Anika Therapeutics, Inc. - Hyalomatrix - Class 2 Recall
Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix is a bi-layered, sterile, flexible, and comfortable wound dressing that acts as an advanced wound care device. It is comprised of a non-woven pad entirely composed of HY AFF 11, a benzyl ester of hyaluronic acid, and a semipermeable silicone membrane, which controls water vapor loss, provides a flexible covering for the wound surface, and adds increased tear strength to the device. The HYAFFl 1 wound contact layer biodegradable matrix acts as a scaffold for cellular invasion and capillary growth. Hyalomatrix is indicated for the manage...
Source: Medical Device Recalls - July 12, 2018 Category: Medical Devices Source Type: alerts
SIE AG, Surgical Instrument Engineering - The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser - Class 2 Recall
The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty, penetrating keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface. In addition, the FEMTO LDV(TM)Z8 Surgical Laser is intended for use in the creation of capsulotomy, phacofragmentation and the cr...
Source: Medical Device Recalls - March 30, 2018 Category: Medical Devices Source Type: alerts
Xintec Corp - OptiLITE MultiUse Holmium Laser Fiber - Class 2 Recall
OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F; Manufactured by CONVERGENT LASTER TECHNOLOGIES The Odyssey 30B is approved for numerous medical procedures. Generally, the primary use of the laser (which includes the fibers) is related to urology, but ultimately it is up to the surgeon except in cases where it is contraindicated. The fibers are usually used in cases involving stones anywhere from the bladder up to the kidneys. Occasionally the laser system is used in soft tissue cases (non-cancerous tumors) in and around the urinary system. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 3, 2017 Category: Medical Devices Source Type: alerts
Spectranetics Corporation - ELCA Coronary Atherectomy Catheter. - Class 2 Recall
ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009, 117-016, 117-205, 120-009 The Laser Catheters are used in conjunction with the Spectranetics CVX-300¿ Excimer Laser System and are intended for use in patients with single or multivessel coronary artery disease, either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA), and who are acceptable candidates for coronary artery bypass graft (CABG) surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 29, 2016 Category: Medical Equipment Source Type: alerts
Spectranetics Corporation - ELCA Coronary Atherectomy Catheter. - Class 3 Recall
ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009, 117-016, 117-205, 120-009 The Laser Catheters are used in conjunction with the Spectranetics CVX-300¿ Excimer Laser System and are intended for use in patients with single or multivessel coronary artery disease, either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA), and who are acceptable candidates for coronary artery bypass graft (CABG) surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 29, 2016 Category: Medical Equipment Source Type: alerts
Spectranetics Corporation - Turbo Elite Atherectomy Catheter - Class 2 Recall
Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159, 423-001, 423-135-01 The Laser Catheters are used in conjunction with the Spectranetics CVX-300¿ Excimer Laser System and are intended for use in patients with single or multivessel coronary artery disease, either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA), and who are acceptable candidates for coronary artery bypass graft (CABG) surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 29, 2016 Category: Medical Equipment Source Type: alerts
Alcon Research, Ltd. - LenSx Laser System - Class 2 Recall
LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 18, 2016 Category: Medical Equipment Source Type: alerts
Monteris Medical Corp - NeuroBiate System SideFireTM Select 2.2 mm Directional Laser Probe - Class 1 Recall
NeuroBiate¿ System SideFireTM Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s SFS000-01,SFS002-01,SFS122-01, SFS222-01, SFS322-01, SFS422-01, SFS522-01. NeuroBiate System SideFire TM Select Directional Laser Probes are part of the NeuroBiate System. The cleared indications for the NeuroBiate System are as follows: The Monteris Medical NeuroBiate¿ System is indicated for use to ablate, necrotize, or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers. The Monteris Medical NeuroBiate¿ System is in...
Source: Medical Device Recalls - May 17, 2016 Category: Medical Equipment Source Type: alerts
Monteris Medical Corp - NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe - Class 1 Recall
NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s SFS000-01,SFS002-01, SFS122-01, SFS222-01, SFS322-01, SFS422-01, and SFS522-01. NeuroBlate System SideFire Select Directional Laser Probes are part of the NeuroBlate System. The Monteris Medical NeuroBlate System is indicated for use to ablate, necrotize, or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers. The Monteris Medical NeuroBlate System is intended for planning and monitoring thermal therapies under MRI visualization. It a...
Source: Medical Device Recalls - May 17, 2016 Category: Medical Equipment Source Type: alerts
Medtronic Navigation, Inc. - Visualase Cooled Laser Applicator System (VCLAS) - Class 2 Recall
Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled Catheter System (CCS). The LDF and disposables (including the CCS) is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology and urology. (Sou...
Source: Medical Device Recalls - May 17, 2016 Category: Medical Equipment Source Type: alerts
Stradis Healthcare, LLC. - Laser Evlt Pack and Laser One Leg Evlt contains Devon Light Glove - Class 2 Recall
Laser Evlt Pack and Laser One Leg Evlt - contains Devon Light Glove Used during surgery (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 8, 2015 Category: Medical Equipment Source Type: alerts
