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

0

GOOD

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:5/17/2013)... , May 17, 2013  Serving a region of ... Rico , Caribbean Imaging and Radiation Therapy (CIRT, ... therapy capabilities with the acquisition of an Elekta Versa HD™ ... Versa HD offers clinicians the versatility to deliver conventional therapies ... while also enabling treatment of highly complex cancers that require ...
(Date:5/17/2013)... , May 17, 2013  Atossa Genetics, Inc. (NASDAQ: ... that Kyle Guse , Chief Financial Officer ... LLP MicroCap Conference on Thursday, May 30, 2013, in ... Hotel. The Company,s presentation is scheduled to ... a live webcast. To access the webcast, go to ...
(Date:5/17/2013)... NATICK, Mass. , May 17, 2013  Boston ... to participate at the annual EuroPCR Scientific Program May ... "We are pleased to present a particularly rich and ... Keith Dawkins , M.D., global chief ... several trials will be presented, including the NG PROMUS ...
Breaking Medicine Technology:Puerto Rico's Caribbean Imaging and Radiation Therapy Center Orders Elekta's New Versa HD System for Treatment of Cancer Patients 2Atossa Genetics to Present at the Second Annual Marcum LLP MicroCap Conference 2Atossa Genetics to Present at the Second Annual Marcum LLP MicroCap Conference 3Boston Scientific Schedule of Major Events and Presentations at EuroPCR 2013 2Boston Scientific Schedule of Major Events and Presentations at EuroPCR 2013 3Boston Scientific Schedule of Major Events and Presentations at EuroPCR 2013 4Boston Scientific Schedule of Major Events and Presentations at EuroPCR 2013 5Boston Scientific Schedule of Major Events and Presentations at EuroPCR 2013 6Boston Scientific Schedule of Major Events and Presentations at EuroPCR 2013 7Boston Scientific Schedule of Major Events and Presentations at EuroPCR 2013 8
... Pharmaceuticals, Inc. (NASDAQ: AVNR ) today announced ... will be highlighted at the 88th Annual Meeting of ... Medicine in Atlanta, GA. ... Progress in Rehabilitation Research : Title: ...
... Oct. 12, 2011 Cempra Holdings, LLC, the parent ... it has filed a registration statement on Form S-1 ... to its proposed initial public offering. Stifel ... are serving as joint book-running managers for the offering. ...
Cached Medicine Technology:Avanir Pharmaceuticals to Present Data at the 2011 American Congress of Rehabilitation Medicine/American Society for Neurorehabilitation Medicine Annual Conference 2Cempra Holdings, LLC Files Registration Statement for Proposed Initial Public Offering 2
(Date:5/19/2013)... FL (PRWEB) May 19, 2013 Exciting ... ®, who is reintroducing a great practice known through ... Brushing, also known as dry body brushing, has so ... Heshelow, founder of Sublime Beauty®. "We love that circulation ... of our largest organ, the skin, is supported through ...
(Date:5/19/2013)... May 19, 2013 Beginning Wednesday, May 29 ... Blood Center (RRVBC) will feature “Hot Dog Wednesdays" and Ice ... RRVBC will provide hot dogs and all the fixin's to ... each day throughout the summer. “Donors are our lifeline. The ... stable and adequate blood supply. This is a small ...
(Date:5/19/2013)... The AMTC team will be screening local ... Convention & Trade Center on June 1st. Professionals and amateurs, ... are free of charge. , Actors, Models and Talent for ... successful artists and grads like Caitlin Kinney - SYTYCD, ... Chris Young - on his Liquid Neon 2013 Tour, Taylor ...
(Date:5/19/2013)... (PRWEB) May 19, 2013 Minor fender ... the road that require parties to the accident to ... for Disease Control and Prevention (CDC) data from 2010, ... of death (i). In fact, in 2005, ... year. Additionally, more than 2.3 million drivers and ...
(Date:5/19/2013)... 2013 The Da Vinci robot lawyers ... in the nation’s first trial involving a Da Vinci ... State Superior Court, was filed by the widow of ... complications in a robot-assisted prostate removal, according to a ... robotic surgery lawsuit alleges those complication’s hastened his ...
Breaking Medicine News(10 mins):Health News:Exciting New Skin Brushes at Sublime Beauty® Bring Health and Beauty Benefits; Celebrities and Models Know the Secret 2Health News:Hot Dog Wednesdays and Ice Cold Slushies Return to Rock River Valley Blood Center for the Summer 2Health News:Actors, Models and Talent for Christ Hosting Auditions in Columbus, GA June 1st in Search of Local Talent 2Health News:Auto Accident Infographic Issued by d’Oliveira & Associates on Steps to Take After a Car Crash 2Health News:Da Vinci Surgical Robot Lawyers at Wright & Schulte LLC Note Recent Developments in Da Vinci Robot Lawsuit Trial 2Health News:Da Vinci Surgical Robot Lawyers at Wright & Schulte LLC Note Recent Developments in Da Vinci Robot Lawsuit Trial 3Health News:Da Vinci Surgical Robot Lawyers at Wright & Schulte LLC Note Recent Developments in Da Vinci Robot Lawsuit Trial 4
... The most common indication worldwide for pediatric transplantation, biliary ... liver disease in newborns. Recently, Childrens Hospital of Pittsburgh ... children with biliary atresia face that lead to the ... of children undergoing their first liver transplant are diagnosed ...
... Washington University School of Medicine in St. Louis have ... proteins associated with the formation of actin networks, which ... to move is important to a broad range of ... disease-causing invaders and how metastasizing cancer cells migrate from ...
... What: , The AACR Annual Meeting features the ... cancer research. This years meeting focuses on ... pipeline, clinical trials, and new approaches to cancer ... of the meeting, the program schedule and related ...
... Workout ... Jude Children,s Research ... Hospital(R), FORT LAUDERDALE, Fla., Jan. 8 ... Ab Crunch Challenge,a fitness challenge that will benefit your waistline and is expected ...
... Pa., Jan. 8 Isolagen(TM), Inc. (Amex: ILE ... Declan Daly,Chief Executive Officer of Isolagen, will present at ... 2008 at 2:00 p.m.,(Pacific Time) / 11:00 a.m. (Eastern ... Francis Hotel in San Francisco, California., The presentation ...
... Top Five New York State Hospitals, ... (OTC Bulletin Board: GLOB), an international e-Health, ... Wyndgate,Technologies(R) division has signed a purchase agreement ... New York for its,advanced transfusion management software, ...
Cached Medicine News:Health News:Children's Hospital physicians publish review of transplant issues in patients with biliary atresia 2Health News:Insights into cell movement likely to aid immune study, cancer research 2Health News:Insights into cell movement likely to aid immune study, cancer research 3Health News:Get a Six Pack While Giving Back 2Health News:Get a Six Pack While Giving Back 3Health News:Isolagen Inc. to Present at the 26th Annual JPMorgan Healthcare Conference 2Health News:Global Med Technologies(R) Adds Eighth SafeTrace Tx(R) Client in New York State 2Health News:Global Med Technologies(R) Adds Eighth SafeTrace Tx(R) Client in New York State 3
These handy dispensers save space and organize gloves in labs and next to hand washers. Clear acrylic. Many other sizes and custom configurations available....
Single side double clamp knife holder for the Vibratome 8000...
... The Starter Package is ... up your laboratory. The package ... accessory kit, additional mounting blocks, ... head, and a rotating stage ...
... Package is a solid solution ... The package includes the Vibratome ... mounting blocks, v-block adapter, specimen ... rotating stage assembly for ease ...
Medicine Products: