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Diagnostic Equipment

🏥 Medical Devices • 6,554 recalls

Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 Product Usage: The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician

Philips Healthcare

Class I - Dangerous

HeartStart MRx Unexpected Pads/Paddles ECG Failure

Jun 20, 2012 Diagnostic Equipment Nationwide View Details →

ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA-19-9XR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods.

Abbott Laboratories

Class I - Dangerous

The six ARCHITECT CA 19-9XR reagent lots are demonstrating a shift up in patient results. The Abbott Controls however do not detect the upward shift and will test within range.

May 30, 2012 Diagnostic Equipment Nationwide View Details →

VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots. Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist your institution in the installation of the system and operations of the operator.

Accumetrics

Class I - Dangerous

The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow P2Y12 Test. Currently the VerifyNow P2Y12 Test reports three values: PRU, BASE and % Inhibition. The change implemented is the elimination of the BASE and % Inhibition results. There will be no change to the reporting of the PRU result whic

Feb 6, 2012 Diagnostic Equipment Nationwide View Details →

USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Brochure: "EXER-REST***A patented, FDA registered, Acceleration Therapeutics device delivering Whole Body Periodic Acceleration to the user for symptomatic relief of a wide range of complaints***Whole Body Periodic Acceleration (WBPA)***WBPA is accomplished utilizing the Ever-Rest device to move the body repetitively head to foot at approximately 140 times a minute. This repetitive motion adds pulses to your natural vascular pulse with each acceleration and deceleration of the body. These additional pulses act on the inner lining of blood vessels (endothelium) throughout the body, a process called pulsatile shear stress, to promote the release of beneficial substances (mediators). These mediators, such as nitric oxide, provide a wide range of health benefits that originate from the user's own body.***Nitric Oxide (NO) is released from endothelial cells that line the arterial walls. NO signals vascular smooth muscle to relax, thereby increasing blood flow throughout the circulation.***NiMS 4400 Biscayne Blvd., Miami, FL 33137 P 305.575.4200 F 305357534201***info@nims-inc.com www.nims-inc.com***NIMS, Acceleration Therapeutics and Exer-Rest are registered trademarks of Non-Invasive Monitoring Systems, Inc.***USA-002 Rev A***" Printed marketing brochure

Non-Invasive Monitoring Systems

Class I - Dangerous

Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims.

May 7, 2012 Diagnostic Equipment Nationwide View Details →

VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist your institution in the installation of the system and operations of the operator.

Accumetrics

Class I - Dangerous

The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow P2Y12 Test. Currently the VerifyNow P2Y12 Test reports three values: PRU, BASE and % Inhibition. The change implemented is the elimination of the BASE and % Inhibition results. There will be no change to the reporting of the PRU result whic

Feb 6, 2012 Diagnostic Equipment Nationwide View Details →

The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. Product Usage: The Holter Analyzer analyzes information collected from ambulatory electrocardiogram recorders worn by patients and used to assist physicians in diagnosis and patient monitoring. In addition, incorrect QTc values are reported after moving the cursor. QTc values are timing events between labeled points of interest in the ECG signal that the physician can mark with the cursor. The software is used to edit a family of events and upon conclusion the software crashes with an error message.

Spacelabs Healthcare

Class I - Dangerous

The firm received reports of the Pathfinder LS software crashing after editing a batch of Holter Analyzer records. The software will stop with an error message requiring a restart. In addition, QTc values will not update after moving the marker.

May 11, 2012 Diagnostic Equipment Nationwide View Details →

US-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Ever-Rest US Brochure US-001 Rev A. Brochure: "***AT acceleration THERAPEUTICS***At Non-Invasive Medical Solutions (NIMS) we pride ourselves on being at the forefront of developing drug free wellness solutions coupled with accredited peer-reviewed clinical research...***Whole Body Periodic Acceleration (WBPA) therapy has been demonstrated to naturally activate the release of beneficial mediators like Nitric Oxide (NO) throughout the vasculature.***Nitric Oxide [NO] supports the functioning of endothelial cells that line the arterial walls. NO signals vascular smooth muscle to relax, thereby increasing blood flow through arteries and veins. With age arterial production and availability of Nitric oxide declines.***NiMS 4400 Biscayne Blvd., Miami, FL 33137 P 305.575.4200 F 305357534201***info@nims-inc.com www.nims-inc.com***NIMS, Acceleration Therapeutics and Exer-Rest are registered trademarks of Non-Invasive Monitoring Systems, Inc.***US-001 Rev A***" Printed marketing brochure

Non-Invasive Monitoring Systems

Class I - Dangerous

Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims.

May 7, 2012 Diagnostic Equipment Nationwide View Details →

Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE). The Cool-Cap is indicated for use in full term infants (more than 36 week gestational age) with clinical evidence of moderate to severe HIE. The device provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with HIE. It is a selective head cooling system for treatment of neonatal hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is placed on the infant's head and the body is warmed using radiant warmers. The Cool-Cap provides 72 hours of monitored cooling. The device is labeled in part: "***OLYMPIC COOL-CAP Cooling Unit***Model No.***Made in USA***Software in this product is Natus Medical Incorporated***"

Natus Medical Incorporated

Class I - Dangerous

Olympic Cool-Cap Cooling Module's power supply failed during treatment. The power supply failure can happen without prior indication and results in the unavailability of the system to begin or continue cooling treatment.

May 21, 2012 Diagnostic Equipment Nationwide View Details →

GE Healthcare Revolution XR/d; GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model numbers: 2259988-2 & 2351505. The Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen system in all general-purpose diagnostic procedures. This device is not intended for mammographic applications.

General Electric Med Systems

Class I - Dangerous

An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath

May 31, 2006 Diagnostic Equipment View Details →

GE Proteus XR/a Radiographic System. GE Medical Systems-Americas Milwaukee, WI. Model Number: 2259988. Product is indicated for use in generating radiographic images of human anatomy in all general-purpose diagnostic procedures. This device is not intended for mammographic applications.

General Electric Med Systems

Class I - Dangerous

An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath

May 31, 2006 Diagnostic Equipment View Details →

Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump -- Class 2 medical device -- SIGMA LLC, Medina, NY 14103 Product Usage: The Spectrum Infusion Pump is intended to be used for the controlled administration of intravenous fluids. These fluids may include blood, blood products or mixtures of pharmaceutical drugs for required patient therapy. The Spectrum is used in conjunction with legally marked intravenous administration sets and medications provided by the user. The Master Drug Library is a software package that will add additional features to the Spectrum Infusion Pump. The Master Drug Library will permit electronic communications with the Spectrum pump and other external peripheral devices. The intended use of the Spectrum pump includes common drug error prevention, through the stand alone settings features of the pump. This includes drug parameter limits and associated drug name identification. With the Master Drug Library, the intended use is to reduce user errors associated with drug selection, drug dose rates, drug dose concentrations, and patient identification associated with the prescribed drug.

Baxter Healthcare

Class I - Dangerous

Recall expansion; the infusion pumps have the potential to fail causing inaccurate flow conditions during use. These conditions range from back flow to free flow, which could result in over-infusion. Sigma's evaluation of subsequent complaints involving failed bearings indicated that the loss or degradation of bearing lubricant to be a more significant contributor to bearing failure than initially believed. Based upon the results of the analysis of these additional failures, Sigma determined that any bearings prior to the latest, improved design may be at risk for failure. Sigma decided to expand the recall of the Spectrum Infusion Pumps to include units manufactured from 1/18/2005 through 11/01/2010.

Jul 6, 2011 Diagnostic Equipment Nationwide View Details →
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