Siemens Medical Solutions USA, Inc - AXIOM Luminos dRFsystem - Class 2 Recall
AXIOM Luminos dRFsystem The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a...
View ArticleIntuitive Surgical, Inc. - Assembly, Patient Side Cart - Class 2 Recall
Assembly, Patient Side Cart, for use with da Vinci Surgical system IS 4000. Product Usage: The patient side cart is positioned at operating room table and contains four arms that are positioned over...
View ArticleLeica Microsystems, Inc. - NCLLCD15: Liquid Mouse Monoclonal Antibody CD15 -...
Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15) is a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative. Product Usage: NCL-L-CD15 is intended for the qualitative...
View ArticleConMed Corporation - MACROLYTE - Class 2 Recall
MACROLYTE Premie Dispersive Electrode, REF 440-2400, Rx ONLY --- CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502-5994 USA Macrolyte Dispersive Electrodes are designed for use with electrosurgical...
View ArticleToshiba American Medical Systems Inc - Solid state xray imager (flat...
Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic stidies used ina interventional setting. K120073. D142204.
View ArticleSmall Bone Innovations, Inc. - SBi RingFix Olive Wires - Class 2 Recall
SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with small osteoarticular fragments, fixation of open and closed fractures, arthrodesis,...
View ArticlePhilips Medical Systems (Cleveland) Inc - Brilliance CT series, iCT, iCT SP,...
Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and the MX8000 Dual v. EXP scanners) Philips Medical Systems,...
View ArticleArrow International Inc - Arrow Percutaneous Sheath Introducer Kits - Class 2...
Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation.
View ArticleMedtronic Neuromodulation - Ascenda Intrathecal Catheter - Class 2 Recall
Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the...
View ArticleStryker Instruments Div. of Stryker Corporation - The NAV3i Platform Power...
The NAV3i Platform Power Box supplies the electrical components with power (e.g. Stryker Nav3 Graphite Camera, SPC-3 Computer, IO-Tablet (touch screen) and the monitor).
View ArticleStryker Instruments Div. of Stryker Corporation - The Stryker NAV3i Platform...
The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-components Stryker Nav3 Graphite Camera, SPC-3 Computer and IO-Tablet (touch screen) as well as the monitor, articulated arms...
View ArticleSiemens Medical Solutions USA, Inc - Class 2 Recall
Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems are radiographic systems used in hospitals, clinics, and medical practices. Ysio enables radiographic and tomographic exposures of...
View ArticleSiemens Medical Solutions USA, Inc - Siemens Emotion 16 and Spirit Computed...
Siemens Emotion 16 and Spirit Computed Tomography Systems Product Usage: The intended use is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission date from...
View ArticleMicroport Orthopedics INC. - PATH(R) THREAD CUP ADAPTOR - Class 2 Recall
PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, NON STERILE, Rx ONLY, Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002. Orthopaedic.
View ArticleMckesson Medical Immaging - Horizon Medical Imaging - Class 2 Recall
Horizon Medical Imaging Horizon Medical Imaging is a medical image and information management application that is intended to receive transmit, store, retrieve, display, print and process digital...
View ArticleCenorin, LLC - HLD Systems - Class 2 Recall
HLD Systems Model 610 Washer/High Level Disinfector. Maximum weight of the Model 610 when filled with water is approximately 450 pounds. The dimensions of the system are: Width: 26.5" (67 cm); Depth:...
View ArticleMaquet Medical Systems USA - PowerLED 700 Surgical Light System - Class 2 Recall
Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient.
View ArticleAlere San Diego, Inc. - Cardiac Marker Test - Class 2 Recall
Alere Triage¿ D-Dimer Test PN 98100, Lot W53884B. The Alere Triage¿ D-Dimer Test is a fluorescence immunoassay to be used with the Alere Triage¿ Meters for the quantitative determination of...
View ArticleLeica Microsystems, Inc. - Leica Ceiling Mount MSF1 - Class 2 Recall
Leica Ceiling Mount MSF-1 for use with M841 and M501 operating microscopes. Article Number 10446781 utilizes a supply voltage of 230 V. Article Number 10446782 utilizes a supply voltage of 110 V....
View ArticleLeica Microsystems, Inc. - Leica Ceiling Mount MS1F & MC1F - Class 2 Recall
Leica Ceiling Mount MS-1F & MC-1F for use with the M500 N operating microscope. Article Number 10446657 utilizes a supply voltage of 110 V. Article Number 10446658 utilizes a supply voltage of 220...
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