BEUDAMED
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    IntelliVue Clinical Information Portfolio (ICIP) Critical Care Release D, Version D.02. Intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by healthcare providers whenever there is a need for generation of a patient record and computation of drug dosage.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code DXJ·October 21, 2009

    Spacelabs Model 91367 SL 2200 Compact Monitor Spacelabs Medical patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products.

    FDA Recall
    Terminated ·Spacelabs Healthcare, Incorporated·Product code DXJ·November 6, 2009

    Spacelabs Medical Flat Panel Display is a touchscreen display, 19-inch thin film transistor liquid crystal display (TFT-LCD). The PNs are 010-1619-00 and 010-1655-00, Models 94260-19 and 94256.

    FDA Recall
    Terminated ·Spacelabs Healthcare, Llc·Product code DXJ·March 20, 2009

    IntelliVue Clinical Information Portfolio Critical Care Release D, Version D.00.00 Product Number: 865047. This device is a clinical information system intended for use in data collection, storage, and management with independent bedside devices, and other systems that are connected either directly or through networks. It is used when there is a need for generating patient records and computation of drug dosage.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code DXJ·March 4, 2008

    Philips IntelliVue Clinical Information Portfolio Software Version D.0, for patient data collection, storage, and management.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code DXJ·May 5, 2009

    CareVue Chart Release C ,Versions C.00.00 through C.00.06 Product No. 862246. This device is a clinical information system intended for use in data collection, storage, and management with independent bedside devices, and other systems that are connected either directly or through networks. It is used when there is a need for generating patient records and computation of drug dosage.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code DXJ·March 4, 2008

    Ultraview Universal Clinical Workstation System Model 90385.

    FDA Recall
    Terminated ·Spacelabs Medical Incorporated·Product code DXJ·January 7, 2005

    Spacelabs Model 91369-24 SL 2400 Compact Monitor Spacelabs Medical patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products.

    FDA Recall
    Terminated ·Spacelabs Healthcare, Incorporated·Product code DXJ·November 6, 2009

    Philips Medical: 865047 IntelliVue Clinical Information Portfolio Release D.03 865209 IntelliVue Clinical Information Portfolio Release E.00 and E.01 865300 IntelliVue Clinical Information Portfolio NICU Link Intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by healthcare providers whenever there is a need for generation of a patient record and computation of drug dosage.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code DXJ·July 8, 2011

    Philips IntelliVue Clinical Information Portfolio (ICIP), Clinical Management System Software Version D.00 through D.03.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code DXJ·October 19, 2010

    Spacelabs flat panel monitor, Model 91415-A

    FDA Recall
    Terminated ·Datex-Ohmeda, Inc.·Product code DXJ·October 29, 2003

    The product is a 19" Spacelabs Medical Flat Panel Display, Model 94260-19, manufactured by ELo Touchsystems

    FDA Recall
    Terminated ·Spacelabs Healthcare, Incorporated·Product code DXJ·October 23, 2009

    CareVue Chart Release C.O Part Number: 862246 Intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by healthcare providers whenever there is a need for generation of a patient record and computation of drug dosage.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code DXJ·May 5, 2009

    Spacelabs Model 91370 SL 2600 Compact Monitor Spacelabs Medical patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products.

    FDA Recall
    Terminated ·Spacelabs Healthcare, Incorporated·Product code DXJ·November 6, 2009

    iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142; iCup DX 11 Panel w/Adulterant, Item No. I-DXA-1117-131; iCup DX 12 Panel w/Adulterant, Item No. I-DXA-1127-023; iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013; iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016; iCup DX Drug Screen, Item No. I-DXA-1127-023 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·October 20, 2015

    iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

    iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

    iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142; iCup DX 11 Panel w/Adulterant, Item No. I-DXA-1117-131; iCup DX 12 Panel w/Adulterant, Item No. I-DXA-1127-023; iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013; iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016; iCup DX Drug Screen, Item No. I-DXA-1127-023 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. ¿¿¿

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·November 25, 2015

    iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015