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Product Recalls

MDCT and CAD Detects Lung Nodules

An article published in the American Journal of Roentgenology describes study findings completed by a Parisian team which indicates the combination of computer-aided detection (CAD) and multidetector CT (MDCT) increases the ability of radiologists to detect lung nodules at an early stage. more...

November 13, 2007 Related topics: Pulmonary, Product Recalls, Imaging, Diagnostic, Radiology

Lead Malfunctions Halt Medtronic ICD Product Sales

Recent data implicates the Sprint Fidelis defibrillation leads used in Medtronic implantable cardiac defibrillators (ICDs) in the death of five patients, though the primary cause of deaths remains to be clarified. As a result, Medtronic opted to suspend sales of the ICDs, as reported by Reuters. more...

October 15, 2007 Related topics: Product Recalls, Monitoring, Quality, Safety, Errors, Cardiology

JAMA, FDA Look at Advisories Issued for AEDs

A recent article in the Journal of the American Medical Association (JAMA) studied FDA Enforcement Reports between January...

Disetronic Recalls D-TRONplus Power Packs used in D-TRONplus Insulin Pumps

Disetronic Medical Systems Inc. announced today a voluntary nationwide recall of the Disetronic D-TRONplus power packs that power...

Welch Allyn PIC 50 AED Class I Recall

Some Welch Allyn PIC 50 Automated External Defibrillators (AEDs), catalog #97108X manufactured from March 2002 through October 2004...

Sleep Apnea Devices Recalled

ResMed, an Australian equipment company, announced a voluntary recall of air-flow generators used for obstructive sleep apnea. The...

Shelhigh Products Seized

Following documentation of serious concerns over flaws in the manufacturing of implantable medical device that may diminish devices...

ICD and CRT-D Advisory from Boston Scientific

Boston Scientific issued a product warning on April 5th secondary to battery problems associated with implantable cardiac defibrillators...

Defibtech Recalls LifeLine and Reviver AEDs

Defibtech initiated a voluntary recall of two semi-automatic External Defibrillators (AEDs): ReviveR and Lifeline on February 22nd. The...

Boston Scientific Announces Nationwide Recall of 51 Mach 1 Guide Catheters

Boston Scientific Corporation today announced that it is voluntarily recalling certain lots of the Mach 1 guide catheters...

Roche Recalls CoaguChek PT Test Strips

Roche Diagnostics is recalling all CoaguChek PT test strips currently in the market because of a potential for...

FDA Has Alaris SE Infusion Pumps Seized

The U.S. District Court for the Southern District of California issued a warrant for seizure of Alaris Signature...

Baxter Withdraws Colleague and Syndeo Pumps from U.S. Market

The U.S. Food and Drug Administration (FDA) today announced that Baxter Healthcare Corp. and two of its top...

Yet More Recalls from Guidant

These last few days Boston Scientific initiated its second wave of recalls for Guidant products. Boston Scientific is...

Welch Allyn Recalls 580 AED20 Defibrillators

MRL, Inc., a company acquired by Welch Allyn in 2003, today announced a voluntary worldwide Class I recall...

Hamilton Medical Issues Alert on certain Raphael Ventilators

Hamilton Medical, Inc. announced today that it is initiating a nationwide voluntary recall of forty seven Raphael ventilators...

Respironics Issues Worldwide Recall of PLV Continuum Ventilator

Respironics, Inc. has voluntarily recalled 269 PLV Continuum ventilators (PLVC I) representing all models and serial numbers of...

FDA Adds Safety Recommendations for Baxter Colleague Pumps

The FDA is recommending additional safety steps on top of those listed by Baxter Healthcare Corporation these past...

Disetronic Medical Systems Recalls ACCU-CHEK Ultraflex Infusion Sets

Disetronic Medical Systems, Inc, announced today a voluntary nationwide recall of all ACCU-CHEK Ultraflex infusion sets, because a...

Guidant Recalls More Pacemakers, Merges with Boston Scientific

Boston Scientific and Guidant announce they signed a $27B merger agreement, so Boston Scientific’s latest bid finally —...

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