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  • Dispositivo 500
  • Fabricante 31827
  • Evento 523
  • Implante 1
Device Recall CLINITRON UPLIFT
  • Modelo / Serial
    Model: Uplift, Serial #CH(all numeric codes).
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The units are primarily leased to hospitals. Units have been sold to hospitals located nationwide and to Canada, Austria, France, Germany Ireland Italy, Netherlands, Spain, Sweden, Switzerland and the United Kingdom.
  • Descripción del producto
    CLINITRON UP-LIFT Air Fluidized Therapy unit.
  • Manufacturer
    Hill-Rom Manufacturing, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall CLINITRON UPLIFT
Device Recall PHS (Professional Hospital Supply)
  • Modelo / Serial
    Lot #250512, Item #489150, 489230, 489267, 489305, 489310, 489347, 489433, 489374, 489412, 489427 and 499448. Lot #250514, Item #489150, 489230 and 489273.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Product was shipped to one distribution center in CA who shipped product to consignees located in CA and NV.
  • Descripción del producto
    PHS, Tubular Stockinette Cotton, 6''x 48'' , 8''x 72'', 4''x 60'' and 4''x 48'' Double Ply, 6''x 72'', 4''x 48'' and 6''x 48''Single Ply and 4''x 4 YDS, 6''x 4 YDS and 3''x 4YDS, 1/pk 25 pk/cs, Manufactured for: Professional Hospital Supply, 41980 Winchester Rd, Temecula, CA 92590.
  • Manufacturer
    Rx Textiles Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall PHS (Professional Hospital Supply)
Device Recall Triton T700 Traction Unit
  • Modelo / Serial
    Model/Catalogue Nos.: 7950 (120 Volt) and 7952 (220 Volt); Serial Numbers: 6211-6230, 1907 & 1920
  • Clasificación del producto
    Physical Medicine Devices
  • Distribución
    IL, CA, TX, OH, FL, LA, WA, NC and DC
  • Descripción del producto
    Triton T-700 Traction Unit,
  • Manufacturer
    Chattanooga Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Triton T700 Traction Unit
Device Recall Triton MP1 Traction Unit
  • Modelo / Serial
    Model/Catalogue Nos.: 7961 (120 Volt) and 7963 (220 Volt); Serial Numbers: 4231 - 4246, 6806 - 6809, 6815, 6818 ¿ 6819, 6824, 6851, 6856 ¿ 6859, 6863, 6870 ¿ 6873, 6878 ¿ 6919, 6921 ¿ 6958
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide. TX, CO, MD, VA, FL, PA, NJ, NY, IN, OH, MI, MO, AL, NV, IL, CA, NM, AR, LA, NE, WA, NC, A, NH, and OK
  • Descripción del producto
    Triton MP-1 Traction Unit
  • Manufacturer
    Chattanooga Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Triton MP1 Traction Unit
Device Recall Clinitron At Home Air Fluidized Therapy Unit
  • Modelo / Serial
    Model 206 (CS), Serial numbers 101671 and 103443 510K: K942184
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Hill Rom primarily leases these units to home care patients and some are sold nationwide.
  • Descripción del producto
    Clinitron At Home¿ Air Fluidized Therapy Unit
  • Manufacturer
    Hill-Rom Manufacturing, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Clinitron At Home Air Fluidized Therapy Unit
Device Recall FLEXICAIR II
  • Modelo / Serial
    Model #13000, IBxxxxxx (where xxxxxxx is a 6-digit number sequence)
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Product is distributed through rental and sale nationwide, Canada, Austria, Germany and the U.K.
  • Descripción del producto
    FLEXICAIR¿ II, Low Airloss Therapy unit.This unit is similar to MC3 but does not have the utility shelf above the foodboard, patient scale or alternate CPR function actuators.
  • Manufacturer
    Hill-Rom Manufacturing, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall FLEXICAIR II
Device Recall FLEXICAIR MC3
  • Modelo / Serial
    MC3, Serial numbers: IC xxxxxx (where xxxxxxx is a 6-digit number sequence).
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Product is distributed through rental and sale nationwide, Canada, Austria, Germany and the U.K.
  • Descripción del producto
    FLEXICAIR MC3¿ Low Airloss Therapy unit
  • Manufacturer
    Hill-Rom Manufacturing, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall FLEXICAIR MC3
Device Recall Stryker 1550 Synergy Extended Stay Stretcher
  • Modelo / Serial
    All stretchers manufactured between 1/1/1993 and 11/07/2003.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    United States, Canada, Hong Kong, Israel, Mexico and Syria.
  • Descripción del producto
    Stryker brand Model 1550 Synergy Extended Stay Stretcher
  • Manufacturer
    Stryker Medical
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Stryker 1550 Synergy Extended Stay Stretcher
Device Recall Tarsys 2G Tilt & Recline Seating System
  • Modelo / Serial
    Serial Numbers: 00Axxx thru 00Lxxx, 01Axxx thru 01Lxxx, and 02Axxx.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The units were shipped to domestic dealerships located nationwide, and to foreign accounts in Canada, China, Oman, and West Indies.
  • Descripción del producto
    Invacare 2G Tarsys Seating System, Model 2GTR.
  • Manufacturer
    Invacare Corporation
  • 3 Events
    • Retiro De Equipo (Recall) de Device Recall Tarsys 2G Tilt & Recline Seating System
    • Retiro De Equipo (Recall) de Device Recall Tarsys 2G Tilt & Recline Seating System
    • Retiro De Equipo (Recall) de Device Recall Tarsys 2G Tilt & Recline Seating System
Device Recall Stryker 1050 hospital stretcher
  • Modelo / Serial
    All units.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    United States and Colombia.
  • Descripción del producto
    Stryker brand Synergy extended stay stretcher; model 1050
  • Manufacturer
    Stryker Medical
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Stryker 1050 hospital stretcher
Xact(tm) Drop Seat Base, a plastic seat support in Xact (tm) Integrated and Xact Individual w/ Dr...
  • Modelo / Serial
    Drop seat bases are not labeled with serial or code numbers, but are found on all wheelchair cushions labeled as Xact Integrated and Xact Individual w/Drop Seat Base.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Product was sold to medical device dealers, primarily pharmacies, nationwide and internationally.
  • Descripción del producto
    Xact(tm) Drop Seat Base, a plastic seat support in Xact (tm) Integrated and Xact Individual w/ Drop seat Base Wheelchair cushions.
  • Manufacturer
    Action Products Incorporated
  • 1 Event
    • Retiro De Equipo (Recall) de Xact(tm) Drop Seat Base, a plastic seat support in Xact (tm) Integrated and Xact Individual w/ Drop seat Base Wheelchair cushions.
Device Recall KCI TriaDyne Proventa
  • Modelo / Serial
    The following serial numbers: TDBK00029, TDBK00294, TDBK00015, TDBK00291, TDBK00026, TDBK00027, TDBK00123, TDBK00124, TDBK00125, TDBK00127, TDBK00128, TDBK00130, TDBK00132, TDBK00136
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Product was distributed domestically in the following states: IN, CA, NH, OR, PA, TX, WI, CO, IA, KS, MO, ID, MA, NC, IL, OH, MN, AZ, NE, HI, PR, NC
  • Descripción del producto
    KCI TriaDyne Proventa Critial Care Therapy System, manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78219. Model number 308900
  • Manufacturer
    Kinetic Concepts, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall KCI TriaDyne Proventa
Device Recall KCI Therapulse II
  • Modelo / Serial
    Serial numbers: TPLK00053, TPLK00052, TPLK00011, TPLK00012, TPLK00013, TPLK00014, TPLK00015, TPLK00016, TPLK00124, TPLK00128, TPLK00132
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Product was distributed domestically in the following states: IN, CA, NH, OR, PA, TX, WI, CO, IA, KS, MO, ID, MA, NC, IL, OH, MN, AZ, NE, HI, PR, NC
  • Descripción del producto
    KCI Therapulse II Air Suspension Therapy Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX 78219. Model number 227080
  • Manufacturer
    Kinetic Concepts, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall KCI Therapulse II
Device Recall KCI
  • Modelo / Serial
    Serial numbers: IVAK00004, IVAK00023, IVAK00028, IVAK00034, IVAK00033, IVAK00032, IVAK00055, IVAK00060, IVAK00062, IVAK00063, IVAK00030, IVAK50000, IVAK00030, IVAK00035, IVAK00027, IVAK00054, IVAK00037, IVAK00041, IVAK00049, IVAK00044, IVAK00045, IVAK00046, IVAK00047, IVAK00048, IVAK00038, IVAK00039, IVAK00042, IVAK00043, IVAK00051, 000038251, 000038253, 000038295, 000038299
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Product was distributed domestically in the following states: IN, CA, NH, OR, PA, TX, WI, CO, IA, KS, MO, ID, MA, NC, IL, OH, MN, AZ, NE, HI, PR, NC
  • Descripción del producto
    KCI Underbed Inverter, Accessory to Powered Flotation Therapy Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX. Model number 201189
  • Manufacturer
    Kinetic Concepts, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall KCI
Device Recall Lift Chairs
  • Modelo / Serial
    Model Numbers: C20, C30, GL358S, GL358L, TMR58, TMR540, TMR560, TMR570T, TMR571, TMR585, DMR670, TMR805, and TMR450.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The recalled product was distributed through dealers nationwide. The affected states are as follows: AL, AR, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, OH, OK, MA, MD, MI, MN, MO,MS, NC, ND, NE, NH, NJ, NM, NV, NY, PA, SC, TN, TX, UT, VA, VT, WA, and WV . There is one government account in FL.
  • Descripción del producto
    Lift Chairs. Electric Positioning Chair.
  • Manufacturer
    Pride Mobility Products Corp
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Lift Chairs
VSP Shock Module (as part of a prosthetic foot).
  • Modelo / Serial
    RFL0001, RFL00008, RFL50006, RFX00001, RFX00002, RFX00012.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide.
  • Descripción del producto
    VSP Shock Module (as part of a prosthetic foot).
  • Manufacturer
    Ossur North America Inc
  • 1 Event
    • Retiro De Equipo (Recall) de VSP Shock Module (as part of a prosthetic foot).
iBOT 3000 Mobility System. Independence IBOT 3000 Mobility System (Stair-climbing wheelchair), C...
  • Modelo / Serial
    Catalog No.''s IT000101-IT000148 (inclusive), Vehicle Identification Numbers (''VIN''s):  020404-000347, 020104-000309, 020504-000357, 021203-000308, 020204-000331, 020104-000314, 020104-000318, 021203-000301, 020304-000335, 020104-000310, 020404-000341, 021203-000299, 020204-000330, 020104-000322, 020204-000332, 020404-000350, 020404-000348, 020304-000340, 020404-000346, 020404-000342, 021203-000307, 020204-000333, 020104-000319, 021203-000304, 020404-000352, 020304-000337, 020304-000336, 020504-000356, 020404-000349, 021203-000305, 020604-000360, 020104-000317, 021203-000306, 020504-000358, 020404-000345, 020504-000354, 020304-000334, 020304-000338, 020404-000344, 020404-000351, 020504-000355, 020104-000323, 020104-000324, 021103-000291, 021203-000300, 020304-000339, 020404-000343, 020504-000359, 020604-000363, 020604-000364, 020604-000365, 020604-000366, 020604-000367, 020604-000368, 020604-000362, 021103-000290, 021103-000295, 020104-000315, 020104-000316, 020104-000320, 020104-000311, 020104-000313, 020204-000329, 020504-000353, 020104-000312, 020604-000361, 021003-000280, 020204-000328, 020104-000321, 020204-000326, 021203-000297, 021203-000298, 021203-000303, 020204-000327, 021103-000294, 021103-000286, 021103-000287, 021003-000273, 021103-000282, 021103-000292, 021103-000293, 021003-000276, 021003-000277, 021103-000285, 021103-000289, 020204-000325, 021103-000296, 021003-000278, 021003-000281, 021003-000272, 021003-000279, 021003-000274, 021003-000275, 021103-000283, 021103-000288, 021103-000284, 021203-000302
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The Independence iBOT 3000 Mobility System was distributed to direct customers in the US, the UK, Ireland, and New Zealand. Ten of the US Direct customers received their devices via the VA. One traning/demo/assessment device was distributed to the firm''s European Support Centre (Ortho Clinical Diagnostics) in France. Two training/demo/assessment devices were distributed to a J&J; representative in Japan.
  • Descripción del producto
    iBOT 3000 Mobility System. Independence IBOT 3000 Mobility System (Stair-climbing wheelchair), Class III restricted medical device. The device is shipped one each per wooden pallet with wooden sides and top retained by reusable bands.
  • Manufacturer
    Independence Technology LLC
  • 1 Event
    • Retiro De Equipo (Recall) de iBOT 3000 Mobility System. Independence IBOT 3000 Mobility System (Stair-climbing wheelchair), Class III restricted medical device. The device is shipped one each per wooden pallet with wooden sides and top retained by reusable bands.
Device Recall Otto Bock 3R90 and 3R92 Single Axis Knee Joint
  • Modelo / Serial
    No lot numbers are used. Recall covers patients who were fit with either of the products between March 1, 2004 and July 9, 2004.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Descripción del producto
    Modular Knee Joint with Friction Brake
  • Manufacturer
    Bock,Otto,Orthopedic Ind,Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Otto Bock 3R90 and 3R92 Single Axis Knee Joint
iBOT 3000 Mobility System, Independence iBOT 3000 Mobility System (Stair-climbing wheelchair), Cl...
  • Modelo / Serial
    Catalog No.''s IT000101-IT000148 (inclusive), Vehicle Identification Numbers (''VIN''s):  020404-000347, 020104-000309, 020504-000357, 021203-000308, 020204-000331, 020104-000314, 020104-000318, 021203-000301, 020304-000335, 020104-000310, 020404-000341, 021203-000299, 020204-000330, 020104-000322, 020204-000332, 020404-000350, 020404-000348, 020304-000340, 020404-000346, 020404-000342, 021203-000307, 020204-000333, 020104-000319, 021203-000304, 020404-000352, 020304-000337, 020304-000336, 020504-000356, 020404-000349, 021203-000305, 020604-000360, 020104-000317, 021203-000306, 020504-000358, 020404-000345, 020504-000354, 020304-000334, 020304-000338, 020404-000344, 020404-000351, 020504-000355, 020104-000323, 020104-000324, 021103-000291, 021203-000300, 020304-000339, 020404-000343, 020504-000359, 020604-000363, 020604-000364, 020604-000365, 020604-000366, 020604-000367, 020604-000368, 020604-000362, 021103-000290, 021103-000295, 020104-000315, 020104-000316, 020104-000320, 020104-000311, 020104-000313, 020204-000329, 020504-000353, 020104-000312, 020604-000361, 021003-000280, 020204-000328, 020104-000321, 020204-000326, 021203-000297, 021203-000298, 021203-000303, 020204-000327, 021103-000294, 021103-000286, 021103-000287, 021003-000273, 021103-000282, 021103-000292, 021103-000293, 021003-000276, 021003-000277, 021103-000285, 021103-000289, 020204-000325, 021103-000296, 021003-000278, 021003-000281, 021003-000272, 021003-000279, 021003-000274, 021003-000275, 021103-000283, 021103-000288, 021103-000284, 021203-000302.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The Independence IBOT 3000 Mobility System was distributed to direct customers in the US, the UK, Ireland, and New Zealand. Ten of the US Direct customers received their devices via the VA. One training/demo/assessment device was distributed to the firm''s European support Centre (Ortho Clinical Diagnostics) in France. Two training/demo/assessment devices were distributed to a J&J; representative in Japan.
  • Descripción del producto
    iBOT 3000 Mobility System, Independence iBOT 3000 Mobility System (Stair-climbing wheelchair), Class III restricted medical device.
  • Manufacturer
    Independence Technology LLC
  • 1 Event
    • Retiro De Equipo (Recall) de iBOT 3000 Mobility System, Independence iBOT 3000 Mobility System (Stair-climbing wheelchair), Class III restricted medical device.
Device Recall Victory Motorized Vehicle
  • Modelo / Serial
    Model SC1600
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The product was shipped to medical supply stores nationwide. There are five foreign accounts in Australia, Canada Great Britain, Italy, and Netherlands. There are twelve government accounts.
  • Descripción del producto
    Victory Motorized Vehicle, 3 wheel Model SC1600
  • Manufacturer
    Pride Mobility Product Corp
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Victory Motorized Vehicle
Device Recall Victory Motorized Vehicle
  • Modelo / Serial
    Model number SC1700
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The product was shipped to medical supply stores nationwide. There are five foreign accounts in Australia, Canada Great Britain, Italy, and Netherlands. There are twelve government accounts.
  • Descripción del producto
    Victory Motorized Vehicle 4 wheels Model SC1700
  • Manufacturer
    Pride Mobility Product Corp
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Victory Motorized Vehicle
Device Recall Cold Therapy Blanket
  • Modelo / Serial
    Item No. T230ST  Codes: 2797009, 3030109, 3403577  Item No. T330ST  Codes: 2930674, 3030125, 3058048, 3138849, 3139008, 3153547, 3316254, 3373996, 3432079, 3754300, 3754300  Item No. T332ST  Codes: 2031177, 2031185, 2797041, 3007785, 3010351, 3086698, 3088511, 3139024, 3213845, 3223980, 3316262, 3355991, 3410312, 3454500, 3531421, 3632046, 3678554,   Item No. T332VQ  Codes: 3138857, 3139032, 3357700, 3521805, 3531448  Item No. T333ST  Codes: 3018628, 3088520, 3155999, 3239471, 3285419, 3356002, 3403614, 3632054, 3670211  Item No. T333VQ  Codes: 2920450, 3030168, 3315631, 3440255, 3592970, 3614315  Item No. T350VQ  Codes: 2847395, 3207429, 3315649, 3592988, 3613574  Item No. T5030ST  Codes: 2930578, 3029950, 3043014, 3239244, 3282728, 3355894, 3403518  Item No. T5030ST-10  Code: 3678431  Item No. T5031ST  Codes: 3057791, 3138902, 3153512, 3239287, 3284491, 3316060, 3373793, 3431990, 3451771, 3505961, 3545436, 3580557, 3631941, 3647871, 3659901, 3668698, 3713647   Item No. T5031ST-10  Codes: 3315622, 3329776  Item No. T5032ST  Codes: 2852864, 2975696, 3088431, 3316107, 3373831, 3401951, 3410208, 3451780, 3531392, 3580581, 3678458  Item No. T5032ST-10  Codes: 2796891, 3009115, 3086680, 3194293, 3207402, 3223947, 3373849, 3631991  Item No. T5032VQ  Codes: 2796903, 2975717, 3138937, 3239332, 3316115, 3373857, 3432028, 3531405, 3580590, 3647918  Item No. T5033ST  Codes: 2904636, 2975750, 3153539, 3194314, 3239359, 3316131, 3355923, 3373873, 3432036, 3449022, 3451798, 3647926, 3698598  Item No. T5033ST-10  Codes: 3030037, 3088458, 3088466, 3239367, 3285355, 3355931, 3403542, 3454462, 3521813, 3532900, 3596436, 3632003  Item No. T5033VQ  Codes: 2678801, 3239375, 3316140, 3401969, 3505995, 3531413, 3580602, 3647977  Item No. T5040ST  Codes: 2181491, 2320147, 2371278, 2430477, 2496871, 2678819, 2904644, 2994521, 3030045, 3088491, 3138953, 3194541, 3239383, 3254495, 3285363, 3440221, 3592937, 3632011, 3678466  Item No. T5050ST  Codes: 2736169, 2753701, 2796954, 2897325, 2975805, 3030053, 3057900, 3194322, 3239404, 3316174, 3449031, 3451827, 3506040, 3713663  Item No. T5050ST-10  Codes: 1909831, 2975821, 3057942, 3316182  Item No. T5050VQ  Codes: 2678827, 2796971, 3057951, 3316191, 3647993  Item No. T5090ST  Codes: 2812011, 2897253  Item No. T530ST  Codes: 2930682, 3030176, 3058072, 3402048  Item No. T531ST  Code: 3402081  Item No. T533ST  Codes: 2753831, 3088554, 3402128  Item No. T540ST  Code: 2215216  Item No. T590ST  Codes: 1910081, 2320059, 2326485
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and Mexico VA Contrat FSS Contract #V797P-4352a (Sept 2002-2007) DoD Contract - DAPA Contract #SP0200-95H-5020 (continous)
  • Descripción del producto
    Cold Therapy Blanket
  • Manufacturer
    DeRoyal Technologies Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Cold Therapy Blanket
Device Recall Dermonosonic NonInvasive Subdermal Therapy System
  • Modelo / Serial
    serial numbers: 8, 960, 1341, 1343, 1344, 1351 through 1354, 1359, 1363, 1365 through 1368, 1372,  1379, 1581, 1583, 1584, 1589 through 1593, 1598, 1599, 1756, 1757, 1760, 1771,  1784, 1786, 1792, 1793, 2001, 2005, 2007, 2012 through 2018, 2020 through 2025, 2028, 2029, 2031, 2032, 2036, 2037, 2038, 2041, 2043, 2044, 2047,  2175, 2176, 2177, 2180 through 2187, 2189 through 2195, 2197, 2198, 2348, 2355 through 2370, 2372, 2373, 2374, 2375, 2376, 2378, 2381, 2382,  2389, 2390, 2392, 2393, 2400 through 2433, 2435, 2436, 2442, 2443, 2453, 2475, 2560,  2562, 2563, 2564, 2565, 2566, 2568, 2569, 2572 through 2579, 2590, 2592, 2593, 2595, 2596, 2597, 2598, and 2599
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    AZ, CA, CO, CT, FL, GA, ID, IL, IA, KS, LA, MA, MI, MN, NV, NJ, NM, NY, NC, OH, OK, OR, SC, SD, TN, TX, UT, VA & WI and to the Phillipines
  • Descripción del producto
    Dermosonic Model 430300 and 440100 Non-Invasive Subdermal Therapy System
  • Manufacturer
    Sybaritic, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Dermonosonic NonInvasive Subdermal Therapy System
Device Recall ElectriCool II
  • Modelo / Serial
    All units manufactured from 3/04-5/04.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The devices were distributed throughout the United States.
  • Descripción del producto
    Electri-Cool II
  • Manufacturer
    Cincinnati Sub-Zero Products Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ElectriCool II
Device Recall Microtemp II.
  • Modelo / Serial
    All units containing version 0.70 software.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The product was distributed to hospitals throughout the United States.
  • Descripción del producto
    Micro-temp II heat therapy unit, model #747.
  • Manufacturer
    Cincinnati Sub-Zero Products Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Microtemp II.
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