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Vista de la lista Vista de las tarjetas
  • Dispositivo 26490
  • Fabricante 33665
  • Evento 35826
  • Implante 7175
Device Recall CareSuite
  • Modelo / Serial
    Software version CareSuite 5.1 and later.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    NJ Canada, Australia, Austria,Denmark, Finland, Germany Norway,Portugal, Sweden, France,Netherlands, Spain.
  • Descripción del producto
    CareSuite" - Critical Care Manager, PACU Manager and Anesthesia Manager || Software: CareSuite 5.1 and later
  • Manufacturer
    Picis Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall CareSuite
Device Recall Medical Maggots with the accessory LeFlap dressing
  • Modelo / Serial
    Batch #: MM-090406 with CCII-0901
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution -- CA, IA, KY, IL, TX, SC & UT.
  • Descripción del producto
    Monarch Labs Medical Maggots with the accessory LeFlap dressing (previously known as Creature Comforts II), 250-500 per vial, Batch #: MM-090406 with CCII-0901. || Maggot therapy is intended to debride serious non-healing (chronic) wounds, and the dressing intended to confine the maggots to the wound.
  • Manufacturer
    Monarch Labs, LLC
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Medical Maggots with the accessory LeFlap dressing
Device Recall SoftPath GUI versions 4.2.3.4, 4.2.4.1, 403.0.3, and 4.3.0.4.
  • Modelo / Serial
    SoftPath GUI versions 4.2.3.4, 4.2.4.1, 4.3.0.3, 4.3.0.4.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: Throughout USA and Canada.
  • Descripción del producto
    SoftPath GUI version 4.2.3.4 2008-06-30 (Manuf Date). || SoftPath GUI version 4.2.4.1 2008-09-30 (Manuf Date). || SoftPath GUI version 4.3.0.3, 2008-07-23 (Manuf Date). || SoftPath GUI version 4.3.0.4 2008-09-16 (Manuf Date). || SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760.
  • Manufacturer
    SCC Soft Computer
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall SoftPath GUI versions 4.2.3.4, 4.2.4.1, 403.0.3, and 4.3.0.4.
Device Recall Soft Query Results Reporting Versions 2.2.0.6.3 and 2.2.0.7.1
  • Modelo / Serial
    Versions 2.2.0.6.3 and 2.2.0.7.1.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution: including states of GA, LA, and NH.
  • Descripción del producto
    Soft Query Results Reporting Versions 2.2.0.6.3 and 2.2.0.7.1. || SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. || Soft Query Results Reporting version 2.2.0.6.3 was released for General Availability on 09/11/03. || Soft Query Results Reporting version 2.2.0.7.1 was released for General Availability on 01/08/04.
  • Manufacturer
    SCC Soft Computer
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Soft Query Results Reporting Versions 2.2.0.6.3 and 2.2.0.7.1
Device Recall SoftPath GUI Releases 3.17 through 4.1.0.
  • Modelo / Serial
    Versions 3.17.5, 3.17.6, 3.17.7, 3.17.8, 4.1.0, and 4.1.1.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide - USA, including the states of CA, CO, CT, FL, GA, IL, IN, LA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, PA, SD, TX, WI, and WV
  • Descripción del producto
    SoftPath GUI Releases 3.17 through 4.1.0. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. || Manufacture/Distribution Dates: || Version 3.17.5 10/14/2003. || Version 3.17.6 03/28/2003. || Version 3.17.7 07/02/2003. || Version 3.17.8 03/03/2004. || Version 4.1.0 07/03/2003. || Version 4.1.1 10/03/2003. || Intended for use in the Pathology Lab for receiving and accessioning specimens, documenting tissue processing, producing material labels, generating final diagnostic reports, and creating billing and management reports for surgical, GYN, NON-GYN, and Autopsy cases.
  • Manufacturer
    SCC Soft Computer
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall SoftPath GUI Releases 3.17 through 4.1.0.
Device Recall SoftPath GUI Versions 3.17 and 4.1
  • Modelo / Serial
    Version 3.17.7.6
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to the states of IN, NC, NH, and NJ.
  • Descripción del producto
    SoftPath GUI Versions 3.17 and 4.1. || SCC Soft Computer 5400 Tech Data Drive, Clearwater, FL 33760. || Manufactured: Version 3.17.7.6 10/23/2003
  • Manufacturer
    SCC Soft Computer
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall SoftPath GUI Versions 3.17 and 4.1
Device Recall SoftPath GUI version 3.17.6.3.1.
  • Modelo / Serial
    Version 3.17.6.3.1.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: One hospital in NY.
  • Descripción del producto
    SoftPath GUI version 3.17.6.3.1. || SCC Soft Computer 34350 US Highway 19 N, Palm Harbor, FL 34684. || Date of Manufacture: || Version 3.17.6.3.1 06/03/2003.
  • Manufacturer
    SCC Soft Computer
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall SoftPath GUI version 3.17.6.3.1.
Device Recall SoftWeb Version 4.0.4.10.1
  • Modelo / Serial
    version 4.0.4.10.1.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution: 1 hospital in Alaska.
  • Descripción del producto
    SoftWeb version 4.0.4.10.1. || SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. || Manufacture Date: 05/16/2006.
  • Manufacturer
    SCC Soft Computer
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall SoftWeb Version 4.0.4.10.1
Device Recall CUSA NXT Ultra Surgical Aspirator System
  • Modelo / Serial
    Serial numbers: NXT1001-1079, NLB0901901IE, NBL0902101IE, NBL0902501IE, NBA1000501IE, NBC1001501IE, NBC1002001IE, NBC1002301IE, NBC1002901IE, NBE1001301IE, NCE1001901IE, NBF1000701IE, NBD1000101IE.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA , including the states of AZ, CA, CO, FL, GA, IA, KY, MN, MO, NV, NY, OH, OR, RI, TX, VA, WI, and the countries of Germany, Hungary, Indonesia, Italy, Netherlands, and Switzerland.
  • Descripción del producto
    Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator System || CUSANXT1:Latex Free, Rx only: || Integra LifeSciences (Ireland) Limited, || County Offaly, Ireland; || Distributed by Integra Life Sciences Corporation || 311 Enterprise Drive || Plainsboro, NJ 08536.
  • Manufacturer
    Integra LifeSciences Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall CUSA NXT Ultra Surgical Aspirator System
Device Recall CUSA NXT Ultra Surgical Aspirator System
  • Modelo / Serial
    Serial numbers: NXT1022, NXT1023, NXT1026, NXT1043, NXT1050, NXT1051, NXT1056, NXT1057, NXT1008, NXT1018, NXT1019, NXT1029, NXT1030, NXT1042, NXT1062, NXT1063, NXT1064, NXT1067, NXT1069, NXT1070, NBC1001901IE.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA , including the states of AZ, CA, CO, FL, GA, IA, KY, MN, MO, NV, NY, OH, OR, RI, TX, VA, WI, and the countries of Germany, Hungary, Indonesia, Italy, Netherlands, and Switzerland.
  • Descripción del producto
    Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator System || CUSANXT2: Latex Free, Rx only. || Integra LifeSciences (Ireland) Limited || County Offaly, Ireland || Distributed by Integra Lifesciences Corporation || 311 Enterprise Drive || Plainsboro, NJ 08536.
  • Manufacturer
    Integra LifeSciences Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall CUSA NXT Ultra Surgical Aspirator System
Sonopet Ultrasonic Surgical System, Model UST-2001, Manufacturer Miwatec Co. LTD, Tokyo, Japan.
  • Modelo / Serial
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04K0304, 04J0289, 08J0992, 09A1012, 09H1072, 06L0637, 02I0106, 06J0615, 05H0386, 06L0642, 08J0990, 07D0693, 02$0069, 06G0552, 03K0181, 01+0027, 05F0356, 05D0339, 08J0988, 07B0650, 07J0802, 03C0138, 05H0404, 04A0203, 05K0435, 03C0136, 04G0258, 07G0755, 01)0011, 06A0464, 06L0627, 07A0647, 03F0132, 08L1001, 02H0100, 05I0409, 02K0111, 02B0056, 07G0760, 08C0879, 04L0321, 03A0122, 08A0851, 02!0044, 09E1084, 07K0804, 04B0213, 06H0582, 07A0646, 04B0199, 02F0088, 05F0364, 07E0698, 09H1066, 09H1089, 06L0631, 06J0609, 06J0607, 03G0145, 03L0193, 06A0451, 04D0227, 01(0003, 06G0563, 03L0192, 07F0723, 09D1060, 01J0023, 02I0107, 03C0137, 05K0430, 03K0182, 03K0183, 01,0035, 02F0083, 01J0020, 08G0944, 06B0481, 06I0596, 08I0967, 08H0960, 08D0883, 02B0050, 07E0708, 06A0454, 01,0036, 01(0005, 06A0453, 08I0964, 09H1077, 06C0495, 06H0584, 07E0707, 04F0240, 07J0796, 06J0612, 08C0880, 08G0943, 06A0466, 06G0559, 04G0249, 04H0267, 03F0142, 06B0483, 03J0176, 06A0455, 09H1067, 07I0778, 06L0625, 03J0177, 05H0382, 08F0917, 05A0334, 09E1087, 05J0418, 07J0801, 06G0565, 02F0086, 02B0048, 05D0346, 01(0009, 07K0816, 06I0593, 07L0835, 08H0957, 07B0660, 05E0353, 05E0348, 07L0819, 06J0611, 05J0427, 04L0324, 01(0004, 08G0945, 03L0191, 02$0066, 06G0562, 06G0564, 09I1097, 08I0979, 02G0095, 05I0412, 06E0537, 09D1054, 05H0402, 03B0128, 06D0517, 01)0014, 01J0016, 05J0420, 05H0384, 04J0287, 06I0592, 08F0918, 04L0322, 04K0299, 07E0710, 06C0503, 06C0507, 06D0522, 06C0501, 06E0535, 06D0520, 06L0640, 06C0506, 06C0499, 06E0536, 06D0521, 06C0504, 06D0518, 06C0505, 05L0443, 06E0538, 06C0500, 07C0676, 06D0519, 06C0498, 06L0639, 06C0502, 08F0920, 05J0426, 05F0369, 04A0207, 07D0690, 04C0218, 02F0082, 05J0428, 05D0347, 04C0221, 01J0017, 08A0841, 03F0131, 08B0853, 02B0047, 06L0638, 08B0863, 05L0442, 04H0265, 02F0087, 06F0548, 07C0674, 09A1011, 04D0229, 04B0215, 06E0540, 02G0098, 03B0127, 04C0220, 03B0129, 02G0097, 03G0151, 10B1162, 02C0062, 02C0063, 02#0060, 02#0061, 02#0064, 05K0437, 09G1044, 09E1083, 05F0372, 05I0411, 05A0326, 08L1000, 07D0692, 06I0597, 02$0070, 07D0689, 05A0333, 04K0307, 08A0849, 07G0761, 08F0924, 08L1005, 01)0015, 08E0897, 07C0664, 08I0983, 08B0852, 08J0993, 07F0726, 09H1068, 09A1015, 05H0405, 04C0200, 07G0751, 07K0817, 07K0818, 05J0425, 05J0419, 06J0613, 05A0331, 05F0360, 06C0496, 05I0415, 08E0899, 09E1081, 03G0146, 09D1056, 09A1022, 08F0923, 03K0180, 07J0794, 06I0595, 03G0144, 06E0528, 08B0864, 03G0147, 06I0594, 03K0185, 07D0694, 04J0290, 06C0493, 07J0800, 02#0059, 07K0814, 07L0837, 08C0881, 07E0715, 07D0695, 06J0614, 08L1004, 04D0228, 05A0330, 04K0308, 06D0523, 06L0632, 09G1043, 08G0942, 02H0099, 06A0462, 04G0255, 04G0256, 05K0436, 09D1062, 08J0987, 07B0649, 06J0608, 02!0045, 07H0773, 04B0214, 04B0212, 04I0274, 08I0963, 08I0978, 03A0123, 07B0662, 04H0268, 06A0452, 07C0665, 03C0139, 05A0332, 07C0677, 04F0238, 08A0838, 06A0463, 04L0320, 07A0645, 07B0648, 04A0202, 01J0019, 05K0429, 03F0141, 07B0659, 01)0013, 09I1098, 04J0286, 01(0001, 04F0239, 03L0188, 06H0581, 02G0091, 07E0697, 10B1167, 09G1064, 04I0276, 04A0206, 04D0226, 09I1095, 05D0337, 08F0919, 03B0130, 07G0737, 04H0266, 07F0728, 08A0850, 05F0370, 08B0862, 05F0361, 08D0884, 08F0922, 06L0626, 10B1172, 10B1170, 10B1159, 10B1165, 10B1164, 10B1169, 10B1160, 10B1173, 03B0140, 10B1157, 10B1163, 10B1161, 10B1174, 10B1158, 10B1171, 08A0844, 02K0115, 02K0116, 02K0117, 02K0118, 04L0319, 04L0316, 03H0135, 05G0393, 07H0768, 07H0769, 08J0995, 08E0909, 09G1078, 09I1092, 09I1093 and 03E0160.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Wordwide
  • Descripción del producto
    Sonopet Ultrasonic Surgical System, Model UST-2001, Manufacturer Miwatec Co. LTD, Tokyo, Japan.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Sonopet Ultrasonic Surgical System, Model UST-2001, Manufacturer Miwatec Co. LTD, Tokyo, Japan.
Device Recall SoftReports versions 1.1.6.x and 1.1.7.x
  • Modelo / Serial
    Versions 1.1.6.x and 1.1.7.x.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution--USA (nationwide) and the country of Canada.
  • Descripción del producto
    SoftReports versions 1.1.6.x and 1.1.7.x || SoftReports version 1.1.6 released 2/2008; Version 1.1.7 released 6/2008. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. || SoftReports is a report designer and web-based report launching tool to be used by knowledgeable, trained, and experienced personnel. It provides the ability to create ad hoc, user defined queries, and reports using data from other SCC products. SoftReports enables users to customize standard reports generated by SCC systems to meet their specific needs. This system performs the following functions: 1. The ability to customize report layouts using beginner, intermediate, or advanced options. 2. The ability to import and export reports. 3. The ability to provide custom desktops to launch SQL's within other SCC applications. 4. The ability to preview and modify layouts specific to users' needs. 5. The ability to modify elements of reports using the comprehensive control formatting toolbar. 6. The ability to incorporate charts and graphics into reports. 7. The ability to modify existing query templates. 8. The ability to create independent and embedded queries. 9. The ability to pars SQL statements and notify users of errors within the syntax. 10. The ability to easily update criteria parameters to indicate input needed for executing queries. 11. The ability to view and print any report that is created using the Designer. 12. The ability to schedule, execute, and track ad-hoc reports. This system does not perform the following functions: 1. SoftReports is not configured to write back to the database. 2. SoftReports does not support user-created Ad Hoc reports being used for diagnostic purposes. 3. SoftReports is not intended to alter the meaning of patient result reports (test reports).
  • Manufacturer
    SCC Soft Computer
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall SoftReports versions 1.1.6.x and 1.1.7.x
Device Recall SoftMic Versions 4.0.4.7 and 4.5.1.3
  • Modelo / Serial
    Versions 4.0.4.7, 4.5.1.3.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA, including the states of CA, CT, DE, FL, IA, KY, MA, MA, MI, MN, NJ, NY, OH, PA, TX, VA, and WI, and the country of Canada.
  • Descripción del producto
    SoftMic Versions 4.0.4.7, 4.5.1.3. || Version 4.0.4.7 Manufactured 02/03/2010. || Version 4.5.1.3 Manufactured 03/18/2010. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760.
  • Manufacturer
    SCC Soft Computer
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall SoftMic Versions 4.0.4.7 and 4.5.1.3
Device Recall SoftID.NET versions 2.0.0.6 2.0.0.19.
  • Modelo / Serial
    Versions: SoftID.NET 2.0.0.6 - 4/3/2007,  SoftID.NET 2.0.0.7 - 6/21/2007,  SoftID.NET 2.0.0.8 - 8/29/2007,  SoftID.NET 2.0.0.9 - 10/01/2007,  SoftID.NET 2.0.0.10 - 10/25/2007,  SoftID.NET 2.0.0.11 - 11/07/2007,  SoftID.NET 2.0.0.12 - 2/08/2008,  SoftID.NET 2.0.0.13 - 5/13/2008,  SoftID.NET 2.0.0.14 - 6/12/2008,  SoftID.NET 2.0.0.15 - 8/15/2008,  SoftID.NET 2.0.0.16 - 10/15/2008,  SoftID.NET 2.0.0.17 - 12/15/2008,  SoftID.NET 2.0.0.18 - 2/02/2009,  SoftID.NET 2.0.0.19 - 5/18/2009.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: AR, CA, FL, IL, IN, KS,LA, MA, MI, MN, MO, NC, ND,NH, NJ, NY, OH, PA, RI, TN, TX, VA and WI.
  • Descripción del producto
    SoftID.NET versions 2.0.0.6 - 2.0.0.19. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. || SoftID.NET is to be used in a medical or clinical laboratory setting by knowledgeable, trained, and experienced professionals. SoftID.NET supports bedside collection of patient specimens used in diagnostic testing. This product is integrated with Soft Computer's SoftLab, SoftScape and can also interface with all other SCC laboratory systems and Hospital Information Systems (HIS).
  • Manufacturer
    SCC Soft Computer
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall SoftID.NET versions 2.0.0.6 2.0.0.19.
Device Recall iSite PACS with Advanced Visualization Tools (AVT)
  • Modelo / Serial
    All units of these iSite PACS.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    iSite PACS with Advanced Visualization Tools (AVT) R7.4V6L1, Versions: 3.6.87, 3.6.92, 4.1.87, and 4.1.92; || Product is manufactured and distributed by Philips Medical Systems, Foster City, CA || iSite PACS: iSite PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RF, RT, MG, SC, VL, as well as hospital/radiology information systems.
  • Manufacturer
    Philips Medical Systems
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall iSite PACS with Advanced Visualization Tools (AVT)
Device Recall iSite PACS with iSite ViewForum Applications
  • Modelo / Serial
    All units of these iSite PACS.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    iSite PACS with iSite ViewForum Applications, R7.4V6 L1 L2, L3, || Versions: 3.6.96, 3.6.101, 3.6.110, 4.1.96, 4.1.101, and 4.1.110 || ; Product is manufactured and distributed by Philips Medical Systems, Foster City, CA || ViewForum Applications: iSite ViewForum Applications is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shelf" standard computer components. iSite ViewForum Applications software receives image data from medical scanning devices, such as CT and MRI, or from image archives. iSite ViewForum Applications performs viewing, image manipulation, communication, printing, and quantification of images.
  • Manufacturer
    Philips Medical Systems
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall iSite PACS with iSite ViewForum Applications
Device Recall Hydrofilm
  • Modelo / Serial
    Lot number: 000543118
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide -- Including CA, GA, IL, MO, MS, TX, and VA.
  • Descripción del producto
    HydroHydrofilm is for use as a post-operative and primary dressing to protect against secondary infection and to cover non-exudating wounds and for use as a secondary dressing for fixation of catheters or cannulae.film, 10cm x 12.5 cm, Paul Hartmann AG, 89522 Heidenhiem, Germany
  • Manufacturer
    Hartmann USA, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Hydrofilm
Device Recall Philips IntelliVue Clinical Information Portfolio
  • Modelo / Serial
    versions D.03, E.0, or E.01 of the software
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA, Canada, Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Kenya, Latvia, Malaysia, Netherlands, Norway, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom.
  • Descripción del producto
    Philips IntelliVue Clinical Information Portfolio software as follows: || 865047 IntelliVue Clinical Information Portfolio Release D.03; 865209 IntelliVue Clinical Information Portfolio Release E.0 and E.01; 865300 IntelliVue Clinical Information Portfolio NICU Link
  • Manufacturer
    Philips Healthcare Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Philips IntelliVue Clinical Information Portfolio
Spectra Optia Apheresis System
  • Modelo / Serial
    Serial Numbers: 1P00100 - 1P00XXX
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA ( nationwide ) and the countries of Australia, Belgium, Canada, Chile, China, Colombia, Hong Kong, India, Japan, Malaysia, Mexico, Pakistan, Republic of Korea, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand and Vietnam.
  • Descripción del producto
    Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215. || A blood component separator used for therapeutic plasma exchanges.
  • Manufacturer
    Caridian BCT, Incorporated
  • 1 Event
    • Retiro De Equipo (Recall) de Spectra Optia Apheresis System
PDI Alcohol Prep Pads packaged in the INRatio kit.
  • Modelo / Serial
    Lot/Unit Codes: 245765R, 245763R, 245766R, 245768, 245769, 252549, 245770, 252020, 252021, 252530, 252532, 252533, 256080, 256081, 256082, 256083, 256084, 256085, 260082, 256086, 256087, 256088, 256089, 256090, 256091, 256092, 261879, 261880.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    PDI Alcohol Prep Pads packaged in the INRatio kit. || PDI Alcohol Prep Pads, 100/box. || Alcohol Prep Pads, packaged in the Alere INRatio¿ 2 PT/INR Home Monitoring Kit; or Hemosense INRatio¿ 2 Prothrombin Time/INR Testing Kit, Self-Test System; Alcohol Prep Pads, packaged in the Hemosense INRatio¿ Prothrombin Time/INR Testing Kit, Self-Test System; || Alcohol Prep Pads, packaged in the INRatio Starter Kit Product || Model Number: 0200086, 0200432, 0100007, 0100072 || The Alere INRatio¿2 PT/INR Home Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The Alere INRatio¿2 PT/INR Home Monitoring System is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The Alere INRatio¿2 PT/ INR Home Monitoring System is not intended to be used for screening purposes. The Alere INRatio¿2 PT/INR Home Monitoring System should only be used with a prescription from your physician. The INRatio2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio2 PT Monitoring System is not intended to be used for screening purposes. The INRatio2 PT Monitoring system should only be used with a prescription from your physician. The INRatio¿ system performs Prothrombin Time (PT) testing on fresh, capillary whole blood. The PT test is the principle assay used to monitor warfarin therapy. Patients taking warfarin and other oral anticoagulants should consult with their healthcare provider before adjusting their dosage. The thromboplastins used in performing PT tests can vary substantially causing differences in results between methods. The International Normalized Ratio (INR) is a mathematical correction of the PT result that adjusts for differences in thromboplastins. Consult your physician for the appropriate therapeutic range for you.
  • Manufacturer
    Alere San Diego
  • 1 Event
    • Retiro De Equipo (Recall) de PDI Alcohol Prep Pads packaged in the INRatio kit.
SoftReports
  • Modelo / Serial
    SoftReports version 1.1.8.2.4 with Hot Fixes 1.7199.7 or 1.7200.7.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    SoftReports version 1.1.8.2.4 with Hot Fixes 1.7199.7 or 1.7200.7. || SoftReports is a web-based report launching tool to be used in a hospital or laboratory environment by knowledgeable, trained, and experienced personnel. SoftReports enables the user to schedule and generate reports for the purpose of viewing and printing data stored in SCC product databases.
  • Manufacturer
    SCC Soft Computer
  • 1 Event
    • Retiro De Equipo (Recall) de SoftReports
Integra
  • Modelo / Serial
    510K #: K981262 Device Listing #: D001100 Item Number C4601S Lot #: 1112631 Lot #: 1112632 Lot #: 1112633 Lot #: 1112634 Lot #: 1112635 Lot #1113361
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    Integra CUSA EXcel Sterile Tips Rx Only || Single Use Only || Product Usage: For usage in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable.
  • Manufacturer
    Integra LifeSciences Corp
  • 1 Event
    • Retiro De Equipo (Recall) de Integra
COBE Spectra
  • Modelo / Serial
    All serial numbers.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution including USA, Canada, Algeria, Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Chile, China, Colombia, Czech Republic, Denmark, Netherlands, UK, Hong Kong, Hungary, India, Italy, Iran, Ireland, Israel, Jordan, Korea, Kuwait, Lebanon, Libya, Luxembourg, Egypt, Finland, France, Germany, Japan, Malaysia, Mexico, Norway, Oman, Pakistan, Philippines, Poland, Portugal, Romania, Russia, Spain, Saudi Arabia, South Africa, Sweden, Switzerland, Taiwan, Thailand, Ukraine, Uruguay, Vatican, Vietnam, and Greece.
  • Descripción del producto
    Caridian BCT COBE Spectra System Blood Warmer, Catalog number 950000000.
  • Manufacturer
    CaridianBCT, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de COBE Spectra
Biotene Moisturizing Mouth Spray
  • Modelo / Serial
    UPC: 048582001558, Lot numbers U3E031, U3E151, U3E211, U3F201, U3G031, U3G171, U3G231 and U3G311.
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution .
  • Descripción del producto
    Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol, GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108. || Biotene Mouth Spray is used for the treatment of dry mouth
  • Manufacturer
    GlaxoSmithKline, LLC.
  • 1 Event
    • Retiro De Equipo (Recall) de Biotene Moisturizing Mouth Spray
SilverStat, 887007
  • Modelo / Serial
    Lot Numbers: 2012-0809; 2012-0903; 2012-1011.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    US in the states of AL, AR, CA, DC, FL, GA, IA, MD, NC, NE, NH, PA, RI, SC, TN, TX, UT, and WV.
  • Descripción del producto
    SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-07. || Product Usage: || SilverStat is an effective barrier to microbial penetration for moderate to heavy exudating partial and full-thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, traumatic and surgical wounds and 1st and 2nd degree bums. SilverStat is indicated for external use only.
  • Manufacturer
    TZ Medical Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de SilverStat, 887007
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Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.

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