Elekta, Inc. - iGUIDE System - Class 2 Recall
iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking System in a radiotherapy environment.
View ArticleNellcor Puritan Bennett Inc. (dba Covidien LP) - PB840 Ventilator Printed...
Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Bennett 840 Ventilator: The Backlight Inverter Printed Circuit Board (BLI PCBA) for the 9.4 Display part...
View ArticleGE Healthcare, LLC - DatexOhmeda S/5MT Compact Airway Module - Class 2 Recall
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. Product Usage: The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is indicated for monitoring...
View ArticleAbility Dynamics LLC - Class 2 Recall
RUSH81 Prosthetic Foot Product Usage: Prosthetic foot for human use
View ArticleSpacelabs Healthcare Inc - Spacelabs Healthcare Ventilator Flexport Interface...
Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07
View ArticlePhilips Medical Systems, Inc. - Trolley Variable Height IRF (for Ingenia 1.5T...
Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Adjustable FlexTrak trolley and Trolley Variable Height IRF is an...
View ArticlePhilips Medical Systems, Inc. - Ingenia HA FLEX TRAK Trolley (for Ingenia...
Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Adjustable FlexTrak trolley and Trolley Variable Height IRF is an...
View ArticleSiemens Medical Solutions Diagnostics - VersaCell X3 Solution and VersaCell...
VersaCell¿ X3 Solution and VersaCell¿ X3 Expansion Pack The VersaCell system is a sample-management system. Using advanced robotics, it connects up to 3 instruments and provides a user interface that...
View ArticleBiomet, Inc. - G7 Positioning Guide Rod - Class 2 Recall
G7 Acetabular System Guide Rod, Prosthesis hip constrained cemented or uncemented metal polymer + additive.
View ArticleBiomet, Inc. - G7 Positioning Guide Post - Class 2 Recall
G7 Acetabular System Guide Post, Prosthesis hip constrained cemented or uncemented metal polymer + additive.
View ArticleNipro Medical Corporation - Class 2 Recall
"***NIPRO Safe Touch Safety Scalp Vein Set STERILIZED WITH ETO GAS Intended to be used for insertion into a patient's vascular system as an indwelling device to administer fluids intravenously or to...
View ArticleSynthes, Inc. - Synthes External Fixation Systems (Small, Medium, Large and...
Synthes External Fixation Systems (Small, Medium, Large and DO) Intended to stabilize and provide treatment for fractures of small bones, for the construction of an external fixation frame for the...
View ArticleNellcor Puritan Bennett Inc. (dba Covidien LP) - Puritan Bennett 840...
Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory support and monitoring for infant, pediatric, and adult patients...
View ArticleConMed Corporation - ConMed ALTRUS Thermal Tissue Fusion System - Class 2 Recall
Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 10mm x 16 cm Catalog Number: 60-9510-001, 2) 10 mm x 23 cm Catalog Number: 60-9511-001, 3) 10 mm x 36 cm Catalog Number:...
View ArticleBioFire Diagnostics, Inc. - FilmArray Blood Culture Identification (BCID)...
FirmArray Blood Culture Identification (BCID) Panel, Model 2.0 The FilmArray Blood Culture Identification (BCID) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test designed...
View ArticleBeckman Coulter Inc. - Coulter DxH Cleaner 10L - Class 2 Recall
Coulter DxH Cleaner 10L, Part No. 628023. For use on UniCel DxH Systems for components that come in contact with blood samples.
View ArticleBeckman Coulter Inc. - Coulter DxH Cleaner 5L - Class 2 Recall
Coulter DxH Cleaner 5L, Part No. 628022. For use on UniCel DxH Systems for components that come in contact with blood samples.
View ArticleBeckman Coulter Inc. - UniCel DxH 800 Coulter Cellular Analysis System -...
UniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465, and B24802. Used for in vitro diagnostic use in screening patient populations found in clinical laboratories.
View ArticleBeckman Coulter Inc. - UniCel DxH 600 Coulter Cellular Analysis System -...
UniCel DxH 600 Coulter Cellular Analysis System, Part No. B23858. Used for in vitro diagnostic use in screening patient populations found in clinical laboratories.
View ArticleZimmer, Inc. - VerSys Hip System, Beaded Fullcoat Stems - Class 2 Recall
VerSys¿ Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581
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