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Diagnostic Equipment

CDI¿ H/S Cuvette The intended use for the CDI¿ H IS Cuvette is as follows: The CDI¿ H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired.

Terumo Cardiovascular Systems

Class I - Dangerous

Terumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor displaying the H/S DISCONNECT AT CUVETTE error message when the CDI H/S Cuvette does not make a proper connection to the CDI H/S Probe. In this situation, blood parameter values for HCT, Hgb, and SO2 do not display.

Dec 11, 2015 Diagnostic Equipment Nationwide View Details →

RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radiation Therapy Treatment Planning System RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs.

RAYSEARCH LABORATORIES AB

Class I - Dangerous

RaySearch became aware of the problem as it was discovered in cooperation with a customer experimenting with the dose calculation on a phantom. The correction concerns two issues found with the dose calculation when using a region of interest (ROI) of type Fixation or Support with material override within the patient outline (External ROI) in RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0).

Sep 1, 2016 Diagnostic Equipment Nationwide View Details →

R&D Systems, Quantikine¿ IVD¿sTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTfR) concentrations in human serum and plasma For in Vitro Diagnostic Use, REF DTFR1.

R & D Systems

Class I - Dangerous

R&D Systems, Inc. received two customer complaints that results of the Controls provided with the Quantikine¿ IVD¿ Human sTfR Immunoassay kit were out of the range high. Internal testing within R&D Systems confirmed a problem with Control results being out of range high.

Aug 24, 2016 Diagnostic Equipment View Details →

TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters. Quantitatively measure whole blood glucose in a professional setting or by self-testing.

Trividia Health

Class I - Dangerous

Product gives incorrect low blood glucose levels.

Jun 28, 2016 Diagnostic Equipment Nationwide View Details →

Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Product Usage: lntracranial pressure measuring probes are used to measure intracranial pressure (intracranial pressure, ICP), so the pressure in the head.

Spiegelberg Gmbh & Co. KG

Class I - Dangerous

In the vast majority of products specified, a shrinkage of the air chamber during sterilization has occurred. Because of these false high readings were displayed in the lower measuring range from 0 to 20 mmHg. The observed measurement error was particularly at the lowest end of the range (to 0 mmHg) up to 8 mmHg.

Dec 29, 2009 Diagnostic Equipment Nationwide View Details →

TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters. Quantitatively measure whole blood glucose in a professional setting or by self-testing.

Trividia Health

Class I - Dangerous

Product gives incorrect low blood glucose levels.

Jun 28, 2016 Diagnostic Equipment Nationwide View Details →

CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven calendar days of study data. The reports are created in PDF format, so they can easily be printed or stored electronically.

Medtronic

Class I - Dangerous

Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp error.

Aug 5, 2016 Diagnostic Equipment Nationwide View Details →

Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"' systems: Myoglobin cTnl Cat No. ADVIA Centaur Calibrator U (2 Pack) - 03684480 (SMN 1 0309996)

Siemens Healthcare Diagnostics

Class I - Dangerous

Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization

Aug 8, 2016 Diagnostic Equipment Nationwide View Details →

TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters. Quantitatively measure whole blood glucose in a professional setting or by self-testing.

Trividia Health

Class I - Dangerous

Product gives incorrect low blood glucose levels.

Jun 28, 2016 Diagnostic Equipment Nationwide View Details →

AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry applications using up to four florescent detection channels.

Beckman Coulter

Class I - Dangerous

Beckman Coulter is recalling the AQUIOS CL System because the use of the reagent carousel can lead to misalignment of the carousel and damage to the prep probe.

Sep 6, 2016 Diagnostic Equipment View Details →

Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps on the market. Up to four Alaris Syringe pump modules can be connected to the Alaris PC unit which is the central programming, monitoring and power supply component for the Alaris System. The syringe pump uses standard, single-use administration sets and syringes with luer-lock connectors.

CareFusion 303

Class I - Dangerous

A software anomaly with the Alaris Syringe module software version 9.15 may cause an infusion to unexpectedly stop when the Syringe module is transitioning from one rate to another.

Aug 8, 2016 Diagnostic Equipment Nationwide View Details →

TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters. Quantitatively measure whole blood glucose in a professional setting or by self-testing.

Trividia Health

Class I - Dangerous

Product gives incorrect low blood glucose levels.

Jun 28, 2016 Diagnostic Equipment Nationwide View Details →

Philips Expression Information Portal (IP5) Model 865471. The IP5 is intended to be used as a secondary display control unit for the Expression MRI Patient Monitoring System and the Expression MR200 MRI Patient Monitoring System.

Invivo

Class I - Dangerous

Frozen Display Numerics and Disabled Menu Keys after extended run time. This customer notification was sent August 22, 2014.

Sep 14, 2014 Diagnostic Equipment Nationwide View Details →

McKesson Radiology, versions 12.1.1 and 12.2 McKesson Radiology (MR) is a Picture Archiving Communication System (PACS). It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.

Mckesson Medical Imaging Group

Class I - Dangerous

The STAT priority icon was not displayed in the Study List when the study was opened.

Jul 12, 2016 Diagnostic Equipment Nationwide View Details →

CADstream software. Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools.

Merge Healthcare

Class I - Dangerous

An incorrect biopsy or missed target could result if the incorrect grid is selected within the application.

Nov 1, 2012 Diagnostic Equipment Nationwide View Details →

St¿ckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage: The St¿ckert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.

Sorin Group USA

Class I - Dangerous

Sorin/LivaNova is initiating a field correction on the S5 Heart-lung machine because of the potential for failure of the Uninterruptible Power Supply.

Aug 25, 2016 Diagnostic Equipment Nationwide View Details →

Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.

Pentax of America

Class I - Dangerous

Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS.

May 31, 2016 Diagnostic Equipment Nationwide View Details →

HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A

Philips Electronics North America

Class I - Dangerous

The handle can separate from the MRx housing due to breakage of mounts on the rear case.

Aug 26, 2016 Diagnostic Equipment Nationwide View Details →

Monitoring Kit with 30mL Flush Device, Item No. 46076-15 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

ICU Medical

Class I - Dangerous

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Aug 10, 2016 Diagnostic Equipment Nationwide View Details →

Transpac IV Monitoring Kit with SafeSet 84inch Arterial Pressure Tubing, Reservoir, Squeeze Flush and 2 Needleless Valves, Item No. 011-42646-66 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

ICU Medical

Class I - Dangerous

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Aug 10, 2016 Diagnostic Equipment Nationwide View Details →

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