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

Navilyst Medical, Inc - PICC Convenience Kit with Accessories - Class 2 Recall
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M0367051, REF/Catalog No. 60M036705, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 8, 2014 Category: Medical Equipment Source Type: alerts

Navilyst Medical, Inc - PICC Convenience Kit with Accessories - Class 2 Recall
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M1318471, REF/Catalog No. 60M131847, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 8, 2014 Category: Medical Equipment Source Type: alerts

Navilyst Medical, Inc - BioFlo PICC with ENDEXO Technology and PASV Valve Technology - Class 2 Recall
BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750191, REF/Catalog No. 75-019, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 8, 2014 Category: Medical Equipment Source Type: alerts

Navilyst Medical, Inc - PICC Convenience Kit with Accessories - Class 2 Recall
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0224751, REF/Catalog No. 60M022475, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 8, 2014 Category: Medical Equipment Source Type: alerts

Navilyst Medical, Inc - PICC Convenience Kit with Accessories - Class 2 Recall
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M1406071, REF/Catalog No. 60M140607, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801 (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 8, 2014 Category: Medical Equipment Source Type: alerts

Navilyst Medical, Inc - PICC Convenience Kit with Accessories - Class 2 Recall
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M0367051, REF/Catalog No. 60M036705, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 8, 2014 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) - Class 2 Recall
Dimension Vista¿ Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista¿ System. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 7, 2014 Category: Medical Equipment Source Type: alerts

Biomet, Inc. - Orthopedic Manual surgical instrument - Class 2 Recall
Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 7, 2014 Category: Medical Equipment Source Type: alerts

Arjo Hospital Equipment AB - Contoura - Class 2 Recall
ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 7, 2014 Category: Medical Equipment Source Type: alerts

Nemschoff Chairs, Inc. - Serenity Treatment Chair - Class 2 Recall
Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. Designed to provide patient comfort during patient treatment sessions. The chair may include a manual control reclining mechanism. Customer configurable models are also available. The Serenity III Exam 791-12E was discontinued 11/1/2010. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 7, 2014 Category: Medical Equipment Source Type: alerts

Biomedix, Inc. - Biomedix SELEC3 I.V. Administration Set - Class 2 Recall
Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek¿ and LDPE/PET pouch. Secondary packaging includes 48 pouched units per box/case. STERILE (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 7, 2014 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Precison 500D - Class 2 Recall
GE Healthcare Precision 500D, Classical R&F System. Product Usage: The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and Pediatric examinations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 3, 2014 Category: Medical Equipment Source Type: alerts

Gendex Corp - eXpertDC intraoral xray - Class 2 Recall
eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 3, 2014 Category: Medical Equipment Source Type: alerts

ELITech Clinical Systems SAS - ENVOY 500 AST Reagent Kit, reference 55255 - Class 3 Recall
ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma using the Envoy 500 Chemistry System. Aspartate aminotransferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart diseases. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 3, 2014 Category: Medical Equipment Source Type: alerts

Ortho-Clinical Diagnostics - VITROS Chemistry Products PHYT Slides - Class 2 Recall
VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 3, 2014 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - Siemens Luminos Agile Max system - Class 2 Recall
Siemens Luminos Agile Max system The Luminos Agile is intended to be used as a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. Luminos Agile is applicable to emergency treatment on an outpatient basis, as well as for bedside examinations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 3, 2014 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - Siemens Uroskop Omnia Max system - Class 2 Recall
Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The system,, which includes a radiologic/urologic treatment table, may be used for urological, gastroenterological and gynecological treatment, planning and diagnostic procedures including but not limited to: "Querying and retrieving patient history information and/or previous diagnosis and images from other modalities; "X-ray examinations of the urogenital area "Ultrasound examinations &...
Source: Medical Device Recalls - October 3, 2014 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - Siemens Ysio Max system - Class 2 Recall
Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. The Ysio Max uses integrated or portable digital detectors ...
Source: Medical Device Recalls - October 3, 2014 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - Siemens Luminos Agile Max system - Class 2 Recall
Siemens Luminos Agile Max system The Luminos Agile is intended to be used as a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. Luminos Agile is applicable to emergency treatment on an outpatient basis, as well as for bedside examinations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 3, 2014 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - Siemens AXIOM Luminos dRF Max system - Class 2 Recall
Siemens AXIOM Luminos dRF Max systems 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 range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 3, 2014 Category: Medical Equipment Source Type: alerts

Invivo Corporation - Expression MR200 MRI Patient Monitoring System - Class 2 Recall
Philips Expression MR200 MRI Patient Monitoring System Model 866120 The Expression MR200 MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signa of patients undergoing MRI procedures and to provide signals for synchronization of the MRI scanner. The Expression MR200 provides monitoring for the following vital sign parameters: ECG, pulse oximetry (SpO2), non-invasive blood pressure (NiBP), and (optional) carbon dioxide (CO2). (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 2, 2014 Category: Medical Equipment Source Type: alerts

Baxter Healthcare Corp. - SPECTRUM Pump - Class 2 Recall
SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 2, 2014 Category: Medical Equipment Source Type: alerts

Intuitive Surgical, Inc. - ASSEMBLY, PATIENT SIDE CART, PS4000 - Class 2 Recall
ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System. Product Usage: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and place...
Source: Medical Device Recalls - October 1, 2014 Category: Medical Equipment Source Type: alerts

Apollo Endosurgery Inc - LapBand AP System - Class 2 Recall
LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I. Product was distributed for both the AP Large and AP Standard sizes. The LAP-BAND System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity related comorbid conditions. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 1, 2014 Category: Medical Equipment Source Type: alerts

Nanosphere, Inc. - Verigene GramPositive Blood Culture Nucleic Acid Test (BCGP) - Class 2 Recall
Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gram-positive (BC-GP) and gram-negative (BC-GN) bacteria and resistance markers. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 1, 2014 Category: Medical Equipment Source Type: alerts

Nanosphere, Inc. - Nanosphere Verigene GramNegative Blood Culture Nucleic Acid Test (BCGN) - Class 2 Recall
Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gram-positive (BC-GP) and gram-negative (BC-GN) bacteria and resistance markers. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 1, 2014 Category: Medical Equipment Source Type: alerts

Nanosphere, Inc. - Verigene GramPositive Blood Culture Nucleic Acid Test (BCGP) - Class 2 Recall
Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gram-positive (BC-GP) and gram-negative (BC-GN) bacteria and resistance markers. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 1, 2014 Category: Medical Equipment Source Type: alerts

Baro-Therapies, Inc - The Rejuvenator - Class 2 Recall
The Rejuvenator Chamber manufactured by Baro-Therapies, Inc. Product Usage: Indicated for relief from general aches and pains brought on by changes in the weather. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 1, 2014 Category: Medical Equipment Source Type: alerts