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 NeuroCare Call Center at 800-356-0007 (press option 2 for Technical Support).

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program: by mail at MedWatch, HF-2, FDA 5600 Fishers Lane, Rockville, MD 20852-9787; by phone at 1-800-332-1088; by fax at 1-800.FDA.0178 or at www.fda.gov/medwatch.

About CareFusion
CareFusion (NYSE: CFN) is a global corporation serving the health care industry with products and services that help hospitals measurably improve the safety and quality of care. The company develops market-leading technologies including Alaris® infusion pumps, Pyxis® automated dispensing and patient identification systems, AVEA®, AirLife™ and LTV® series ventilation and respiratory products, ChloraPrep® products, MedMined™ services for data mining surveillance, Nicolet™ neurological monitoring and diagnostic products, V. Mueller® surgical instruments, and an extensive line of products that support interventional medicine. CareFusion employs more than 14,000 people across its global operations. More information may be found at www.carefusion.com.

 


'/>"/>
SOURCE CareFusion
Copyright©2010 PR Newswire.
All rights reserved

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:6/24/2016)... 24, 2016  Arkis BioSciences, a leading innovator ... more durable cerebrospinal fluid treatments, today announced it ... funding is led by Innova Memphis, followed by ... private investors.  Arkis, new financing will accelerate the ... market release of its in-licensed Endexo® technology. ...
(Date:6/23/2016)... DUBLIN , June 23, 2016 ... "Dialysis Devices Global Market - Forecast to 2022" report ... is the treatment method for the patients with kidney failure, ... and excess fluid from the patient,s blood and thus the ... sodium, potassium and chloride in balance. Increasing ...
(Date:6/23/2016)... 23, 2016 Research and Markets ... Market by Type (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic ... Coating, Parenteral) - Global Forecast to 2021" report ... The global pharmaceutical excipients market is projected to ... of 6.1% in the forecast period 2016 to 2021. ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 27, 2016 , ... Quality metrics are proliferating in cancer care, and ... in the eye of the beholder, according to experts who offered insights and commentary ... of Managed Care. For the full issue, click here . , For the ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many women are ... with endometriosis. These women need a treatment plan to not only alleviate symptoms ... can help for preservation of fertility and ultimately achieving a pregnancy. The specialists ...
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency Room , the largest ... as the Medical Director of its new Mesquite-Samuell Farm facility. , “We are ... Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published ... unfamiliar with. The article goes on to state that individuals are now more comfortable ... less common operations such as calf and cheek reduction. The Los Angeles area medical ...
(Date:6/24/2016)... ... June 24, 2016 , ... Global law firm Greenberg Traurig, P.A. announced that ... chosen by their peers for this recognition are considered among the top 2 percent ... special honors as members of this year’s Legal Elite Hall of Fame: Miami ...
Breaking Medicine News(10 mins):