Carefusion 209, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
- FDA recalls
- 4
At a glance
Market reach
- United States
- FDA recalls
What Carefusion 209, Inc. makes
Carefusion 209, Inc. manufactures disposable concentric and monopolar needles for diagnostic procedures, including the Teca Elite line. The company also produces wireless electroencephalography (EEG) systems, such as the Nicolet Wireless EEG, for neurological monitoring. Additionally, it supplies the Nicolet EDX platform, which supports advanced diagnostic imaging and analysis.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Carefusion Nicolet Edx Ref K120979
Regimes: 510(k) Registry: 510(k)Teca Elite Disposable Concentric Needles Ref K112034
Regimes: 510(k) Registry: 510(k)Nicolet Wireless Eeg Ref K103140
Regimes: 510(k) Registry: 510(k)Teca (Tm) Elite Disposable Monopolar Needles Ref K111131
Regimes: 510(k) Registry: 510(k)Carefusion Nicolet Edx Ref K112052
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 4 recalls initiated by Carefusion 209, Inc., the earliest on 2011-10-05 and the most recent on 2011-12-16. By recorded status: 4 terminated. The reasons filed fall into these groups: labeling or instructions for use, software or firmware and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 16 Dec 2011 Z-0737-2012 Unclassified (pre-2012) Terminated Under certain work flow processes, when selecting a new patient name in NicVue, the associated exams list may not properly refresh, and may continue to display the previous patient's exams.
Full distribution text
- 5 Oct 2011 Z-0799-2012 Unclassified (pre-2012) Terminated CareFusion is recalling the NicoletOne Software v5.60.2-5.71.4 used with the Cortical Stimulator Control Unit. It is possible that during cortical stimulation the electrode annotation label may be incorrect on the screen and in the report when the current is correctly delivered through the selected electrodes.
Also, it has been determined that the stimulus cable connection in the Cortical S
Full distribution text
- 5 Oct 2011 Z-0800-2012 Unclassified (pre-2012) Terminated CareFusion is recalling the NicoletOne Software v5.60.2-5.71.4 used with the Cortical Stimulator Control Unit. It is possible that during cortical stimulation the electrode annotation label may be incorrect on the screen and in the report when the current is correctly delivered through the selected electrodes.
Also, it has been determined that the stimulus cable connection in the Cortical S
Full distribution text
- 5 Oct 2011 Z-0801-2012 Unclassified (pre-2012) Terminated CareFusion is recalling the NicoletOne Software v5.60.2-5.71.4 used with the Cortical Stimulator Control Unit. It is possible that during cortical stimulation the electrode annotation label may be incorrect on the screen and in the report when the current is correctly delivered through the selected electrodes.
Also, it has been determined that the stimulus cable connection in the Cortical S
Full distribution text
- 16 Dec 2011 Z-0737-2012 Unclassified (pre-2012) Terminated Under certain work flow processes, when selecting a new patient name in NicVue, the associated exams list may not properly refresh, and may continue to display the previous patient's exams.
Frequently asked questions
How many devices does Carefusion 209, Inc. have in the registry?
The registry currently lists 5 devices for Carefusion 209, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Carefusion 209, Inc.'s devices?
Among its 5 most recently registered devices, Carefusion 209, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Carefusion 209, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Carefusion 209, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Carefusion 209, Inc.?
FDA recall records list 4 recalls initiated by Carefusion 209, Inc., the most recent initiated on 16 Dec 2011. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Carefusion 209, Inc. in the registry?
The most recently registered devices listed for Carefusion 209, Inc. include CAREFUSION NICOLET EDX, TECA ELITE DISPOSABLE CONCENTRIC NEEDLES, NICOLET WIRELESS EEG and TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES.