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This page shows you the most recent publications within this specialty of the MedWorm directory. This is page number 6.

Nihon Kohden America Inc - Remote Network Station 9703 - Class 2 Recall
Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24, Software version 02.40. The RNS 9703 is intended for use by medical professionals to provide secondary cardiac and vital signs monitoring for multiple patients within a medical facility. The device will display physiological data from up to 16 telemetry receiver/transmitters or bedside monitors and generate an alarm when a measured parameter falls outside a pre-set limit or when life threatening arrhythmias are detected. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 30, 2015 Category: Medical Equipment Source Type: alerts

Integra LifeSciences Corp. d.b.a. Integra Pain Management - Integra Long Epidural Steroid Injection Needle (Tuohy Needle) - Class 2 Recall
Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Metal Stylet, Calibrations (10BX), Catalogue No. PITRW1850. Used to administer steroid medication in the epidural space. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 30, 2015 Category: Medical Equipment Source Type: alerts

Dako North America Inc. - Test Request Distributor (TRD) 1.3 and 1.4 of Dakos OMNIs System software module - Class 2 Recall
Test Request Distributor (TRD 1.3 and TRD 1.4) of the Dako Omnis System Product Usage: The Test Request Distributor (TRD) is intended to distribute patient case, appropriate parts information, track changes, and transform test requests from LIS or manual entries to connected Dako systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 30, 2015 Category: Medical Equipment Source Type: alerts

Therasage, LLC. - FARInfrared Heat Home Sauna, 3 person - Class 2 Recall
FAR-Infrared Heat Home Sauna, 3 person Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety . (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 29, 2015 Category: Medical Equipment Source Type: alerts

Therasage, LLC. - Portable FAR Infrared Sauna - Class 2 Recall
Portable FAR Infrared Sauna Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety . (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 29, 2015 Category: Medical Equipment Source Type: alerts

Therasage, LLC. - FARInfrared Heat Home Sauna, 2 person - Class 2 Recall
FAR-Infrared Heat Home Sauna, 2 person Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety . (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 29, 2015 Category: Medical Equipment Source Type: alerts

Spacelabs Healthcare Inc - Ultraview SL Command Modules, Model 91496M, upgraded with the Masimo SpO2 Option - Class 2 Recall
Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network f...
Source: Medical Device Recalls - April 29, 2015 Category: Medical Equipment Source Type: alerts

Biocare Medical, LLC - CD99 - Class 2 Recall
CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: Provides adjunctive diagnostic information following the primary diagnosis of a neoplasm by conventional histopathology methods. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2015 Category: Medical Equipment Source Type: alerts

Beckman Coulter, Inc. - MicroScan Pos Combo Panel Type 33 - Class 2 Recall
MicroScan Pos Combo Panel Type 33 (PC33): Catalog number B1017-211 MicroScan Pos Combo 33 B1017-211 panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic and facultative anaerobic gram-positive bacteria. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2015 Category: Medical Equipment Source Type: alerts

GA Industries - Logicon Caries Detector - Class 2 Recall
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2015 Category: Medical Equipment Source Type: alerts

GE Healthcare - OptimaXR200amx - Class 2 Recall
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2015 Category: Medical Equipment Source Type: alerts

GE Healthcare - BrivoXR285amx - Class 2 Recall
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2015 Category: Medical Equipment Source Type: alerts

GE Healthcare - OptimaXR220amx - Class 2 Recall
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2015 Category: Medical Equipment Source Type: alerts

Coloplast Manufacturing US, LLC - Class 2 Recall
Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250. Product Usage: The Coloplast Genesis Penile prosthesis is a flexible silicone elastomer device designed to be implanted into the penis for the management of erectile dysfunction. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2015 Category: Medical Equipment Source Type: alerts

Baxter Healthcare Corp. - Class 2 Recall
The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use device for the control of intermittent bolus doses of medication based on patient demand. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2015 Category: Medical Equipment Source Type: alerts

Coloplast Manufacturing US, LLC - Genesis Malleable Penile Prosthesis - Class 2 Recall
Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250. Product Usage: The Coloplast Genesis Penile prosthesis is a flexible silicone elastomer device designed to be implanted into the penis for the management of erectile dysfunction. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2015 Category: Medical Equipment Source Type: alerts

Zimmer Gmbh - Zimmer Anatomical Shoulder Handle for Rasp - Class 2 Recall
Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2015 Category: Medical Equipment Source Type: alerts

Medical Components, Inc dba MedComp - 9F Plastic Dual Port - Class 2 Recall
9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection port, a self-sealing membrane and a detachable catheter. The port systems provide repeated vascular access and are applicable for delivery of: medications, intravenous fluids, blood products, parenteral nutrition, and for venous blood sampling. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2015 Category: Medical Equipment Source Type: alerts

Biosense Webster, Inc. - WEBSTER Fixed Curve Catheter with Auto ID Technology - Class 2 Recall
WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure; i.e., stimulation and recording only. Catalog No: 01085413 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2015 Category: Medical Equipment Source Type: alerts

Cyberonics, Inc - VNS Therapy Generator - Class 2 Recall
VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC 100 Cyberonics Boulevard, Houston, Texas 77058, USA (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2015 Category: Medical Equipment Source Type: alerts

Beckman Coulter, Inc. - Microscan Neg Breakpoint Combo 47, B1017417 - Class 2 Recall
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/BP Combo 47, Catalog B1017-417 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2015 Category: Medical Equipment Source Type: alerts

Beckman Coulter, Inc. - Microscan Neg/Urine Combo 61, B1017414 - Class 2 Recall
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 61, Catalog B1017-414 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2015 Category: Medical Equipment Source Type: alerts

Beckman Coulter, Inc. - Microscan Neg MIC 38, B1017412 - Class 2 Recall
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg MIC 38, Catalog B1017-412 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2015 Category: Medical Equipment Source Type: alerts

Beckman Coulter, Inc. - Microscan Neg Combo 50, B1017406 - Class 2 Recall
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg Combo 50, Catalog B1017-406 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2015 Category: Medical Equipment Source Type: alerts

Beckman Coulter, Inc. - Microscan Neg/Urine Combo 55, B1017409 - Class 2 Recall
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 55, Catalog B1017-409 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2015 Category: Medical Equipment Source Type: alerts