Navigation Links
CareFusion Provides Update on Voluntary Recall of Neurological Monitoring Software and Devices
Date:1/20/2012

SAN DIEGO, Jan. 20, 2012  /PRNewswire/ --CareFusion issued the following update regarding its voluntary recall of the Nicolet® Cortical Stimulator Control Unit, Nicolet® C64 Stimulus Switching Unit (SSU) Amplifier and NicoletOne Software with Cortical Stimulator License. The FDA has classified this action as a Class I recall.

The company initiated the voluntary recall, which affects 125 devices and 58 software licenses, in October 2011. The devices and software subject to the recall were distributed to 38 customers between May 7, 2009 and July 11, 2011. This action has no effect on the manufacture or distribution of current products.

There is no change to the remediation plan previously communicated by the company. CareFusion has already completed the majority of the corrective actions on affected products in the United States.

In October 2011, the company sent an urgent Medical Device Recall Notification to customers stating the identified potential risks associated with the Cortical Stimulator Control Unit, SSU Amplifier and related software applications. Affected units have the potential to develop a short circuit, and affected software licenses may display or capture the incorrect electrode annotation label on the Cortical Stimulator Control Unit screen and in the associated report. A Class I recall is defined as a reasonable probability of serious adverse health consequences or death associated with use of the defective units.

In the notification letter, customers were provided serial and version numbers of affected hardware and software. This information is available at http://www.carefusion.com/customer-support/alerts-notices/medical-device-recall-nicoletone-software.aspx.

Instructions to customers
Customer inquiries related to this action should be addressed to the CareFusion
'/>"/>

SOURCE CareFusion
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. CareFusion Receives Federal Data Encryption Certification for Alaris® Infusion System
2. CareFusion Announces Preliminary Second Quarter Results
3. CareFusion Provides Update on Previously Announced Ventilator Recall
4. CareFusion Showcases Medication Management Technologies at American Society for Health-System Pharmacists Conference
5. CareFusion Launches Wireless Diagnostic and Monitoring Neurological Device
6. CareFusion Announces New Ventilation Solution to Help Hospitals Provide Improved Patient Care and Reduce Costs
7. CareFusion Initiates Class I Recall of EnVe Ventilators
8. CareFusion Launches New Emergency Transport Ventilator
9. B. Braun Medical Sues CareFusion for Patent Infringement
10. CareFusion Reports Fourth Quarter and Fiscal 2011 Results
11. CareFusion and ResMed Announce Distribution Agreement for U.S. Hospital Market
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/30/2015)... , June 30, 2015 Pulse Light ... a survey to Rosacea sufferers as part of their ongoing ... Rosacea sufferers found effective for their Rosacea. The survey participants ... comprised 47% men and 53% women. The results ... participants did not consider or attempt to visit their GP ...
(Date:6/30/2015)... , June 30, 2015  Ardelyx, Inc. (NASDAQ: ... cardio-renal, gastrointestinal and metabolic diseases, today announced that the ... 14, 2015, from 8:00 a.m.- 1:00 pm EDT in ... The Ardelyx senior management team will present an ... compound, tenapanor, which has completed Phase 2b clinical trials ...
(Date:6/30/2015)... , BERKELEY, Kalifornien, und KOPENHAGEN, Dänemark, ... Biologics, Inc. , ein Weltmarktführer der klinischen ... anderen therapeutischen Proteinen, gab heute bekannt, dass ... der Produktionskapazität den Ausbau der nordamerikanischen Produktionsanlage ... mit der Ergänzung  einer Einweg-Anlage Bioreactor 6Pack™ ...
Breaking Medicine Technology:84% of Rosacea Sufferers Say NHS Treatments Were "Ineffective" New Survey Reveals 284% of Rosacea Sufferers Say NHS Treatments Were "Ineffective" New Survey Reveals 3Ardelyx to Host Inaugural R&D Investor Day in New York City on July 14, 2015 2CMC Biologics baut GMP-Produktionskapazität in den USA aus 2CMC Biologics baut GMP-Produktionskapazität in den USA aus 3
... Mass., Oct. 26, 2011 Idenix Pharmaceuticals, Inc. (NASDAQ: ... financial results for the third quarter of 2011 on Wednesday, ... Idenix management will host a conference call at 4:30 p.m. ... financial results for the third quarter of 2011 and provide ...
... MECHANICSBURG, Pa., Oct. 26, 2011 One out of three ... according to an Opinion Research/Select Medical telephone poll. Against that ... a statement today reminding the American public that influenza season ... chronic lung disease such as asthma or COPD (Chronic Obstructive ...
Cached Medicine Technology:Idenix to Host Conference Call Discussing Third Quarter and Nine Month 2011 Financial Results and Announces Presentations at the American Association for the Study of Liver Diseases Meeting (AASLD) 2Poll: One Out of Three U.S. Adults Not Planning to Get Flu Shot This Year 2
(Date:6/30/2015)... , ... June 30, 2015 , ... According to a ... 2007 to 2013 while heroin-related deaths more than tripled in the same period—leading a ... Novus Medical Detox Center , a leading Florida-based drug treatment facility, asserts that ...
(Date:6/30/2015)... ... 30, 2015 , ... ADVOCATE, the premier provider of radiology ... exclusive billing agreements with Jackson Radiology Associates in Jackson, TN. , ... of billing process software functionality called Experience Based Technology (EBTTM). EBTTM improves ...
(Date:6/30/2015)... ... ... On June 26, 2015, Harper’s Bazaar Magazine in an article titled “5 ... not expect to cause acne flare-ups. The list includes pillowcases, cell phones, ... are clogged pores and bacteria and each of the named triggers unexpectedly creates a ...
(Date:6/30/2015)... Jacksonville, FL (PRWEB) , ... June 30, 2015 ... ... in Jacksonville, reported today it has more than doubled the size of its ... , The center’s medical staff -- which includes physicians, nurse practitioners and physician ...
(Date:6/30/2015)... (PRWEB) , ... June 30, 2015 , ... ... 26th Annual Alzheimer's Association of Colorado's Education Symposium on November 9, 2015 at ... is honored to host a conversation with Kim and Ashley Campbell, the wife ...
Breaking Medicine News(10 mins):Health News:Novus Medical Detox Center Urges Education and Action as New DEA Report Reveals Rising Heroin Use and Deaths 2Health News:Novus Medical Detox Center Urges Education and Action as New DEA Report Reveals Rising Heroin Use and Deaths 3Health News:Novus Medical Detox Center Urges Education and Action as New DEA Report Reveals Rising Heroin Use and Deaths 4Health News:ADVOCATE Wins Billing Agreements with Jackson Radiology Associates 2Health News:A List of 5 Surprising Acne Triggers and the Latest Acne Treatment Options 2Health News:Lakeview Health, a Nationally Recognized Drug Rehabilitation Center in Florida, Doubles Size of Medical Staff 2Health News:Family of Singer Glen Campbell to Discuss Living with Dementia at the Alzheimer's Association of Colorado's 26th Annual Education Symposium 2
... to Focus on G-Protein Coupled Receptors, BERWYN, ... discovery,company focused on developing pharmaceutical products targeting G-protein,coupled ... $24 million,Series A financing. Alta Partners and Healthcare ... syndicate that included New Enterprise Associates and,Polaris Venture ...
... GAINESVILLE, Fla., March 5 In a strange ... new, non-surgical infertility treatment started,reporting unusual side-effects: increased ... reproductive tract adhesions, caused,unexpected results in some patients ... physical therapist Belinda Wurn. (see, http://www.clearpassage.com ), ...
... have discovered an Antarctic fish species that adopts a ... week in the journal PLoS ONE, the online journal ... Antarctic Survey (BAS) and the University of Birmingham reveal, ... coriiceps effectively puts itself on ice to survive the ...
... Calif., March 5 "I have never,experienced greater satisfaction ... cells.", The quote, from Greg Smith, CEO, Mountain ... the storage of umbilical cord blood by,CorCell, Philadelphia, Pa., ... Mr. Smith continues: "The thought of possibly protecting ...
... entered into by,Airborne Health, Inc. - the maker of ... In that settlement, Airborne,Health, Inc. agreed to pay approximately ... California. The settlement has been reported in the,national media ... Airborne Health,Inc., But there is more to the ...
... Secretary of Health,Dr. Calvin B. Johnson met with ... to discuss Governor Edward G. Rendell,s plan to ... of uninsured adults,through his "Cover All Pennsylvanians" proposal., ... help prevent disease,successfully manage chronic diseases such as ...
Cached Medicine News:Health News:Trevena, Inc. Announces $24 Million Series A Financing 2Health News:Trevena, Inc. Announces $24 Million Series A Financing 3Health News:Surprise Orgasms Baffle Women Undergoing New Infertility Treatment 2Health News:Hibernation-like behavior in Antarctic fish -- on ice for winter 2Health News:Greatest Satisfaction Preserving Granddaughter's Cord Blood Stem Cells 2Health News:Information About The Airborne Health, Inc. Settlement, and Other Ongoing Litigation Alleging False and Deceptive Marketing Of Airborne(R) 2Health News:Information About The Airborne Health, Inc. Settlement, and Other Ongoing Litigation Alleging False and Deceptive Marketing Of Airborne(R) 3Health News:Health Secretary Stops in Erie County to Call for Health Insurance for all Pennsylvanians 2
... are an ophthalmologic medical device designed for ... -1.00 to -3.00 diopters.* When placed in ... central optical zone, the product reshapes the ... is composed of two prescription inserts, each ...
... is our most affordable basic centrifuge. The 614 is ... 614 is also the quietest small lab centrifuge on ... up to six (6) test tubes up to 15ml ... lid safety switch and is UL/CSA compliant. ...
... is a simple one, help physicians serve ... image, the physician is provided with significantly ... structures. This technical accomplishment is combined with ... The device features: ...
... Contour Eyelid Implants feature a proprietary ... of the ocular globe. The Contour ... in the eyelid because the tapered lower ... lower profile. Surfaces and edges of the ...
Medicine Products: