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  • Dispositivo 500
  • Fabricante 31827
  • Evento 523
  • Implante 1
Device Recall Unloader Custom
  • Modelo / Serial
    Item No: B-122500020 B-122600020
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    U.S. distribution to the following; AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, RI, TN, TX, UT, VA, VT, WA, WI, WV
  • Descripción del producto
    Unloader Custom || Product Usage: || Unloader Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
  • Manufacturer
    Ossur H / F
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Unloader Custom
Device Recall Extreme Custom
  • Modelo / Serial
    Item No: B-108500010 B-108500020 B-108600010 B-108600020 B-123500020 B-123600020
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    U.S. distribution to the following; AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, RI, TN, TX, UT, VA, VT, WA, WI, WV
  • Descripción del producto
    Extreme Custom || Product Usage: || Extreme Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
  • Manufacturer
    Ossur H / F
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Extreme Custom
Device Recall Papoose Infant Spine Immobilizer, Papoose; Papoose w/replacement pads; Papoose w/o...
  • Modelo / Serial
    Item # Item Description: PA-100 Papoose PAR-100 Papoose w/replacement pads PO-100 Papoose w/o PO front POR-100 Papoose w/o PO front w/pad   All lot numbers from MX140101 to MX150930
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    U.S. distribution to the following; AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, RI, TN, TX, UT, VA, VT, WA, WI, WV
  • Descripción del producto
    Papoose Infant Spine Immobilizer || Item # Item Description: || PA-100 Papoose || PAR-100 Papoose w/replacement pads || PO-100 Papoose w/o PO front || POR-100 Papoose w/o PO front w/pad || Product Usage: || The Papoose Infant Immobilizer is an external class I orthotic device used to securely immobilize the head and spine in the proper anatomical airway and spinal alignment. The occipital shape protects against positional plagiocephaly.
  • Manufacturer
    Ossur H / F
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Papoose Infant Spine Immobilizer, Papoose; Papoose w/replacement pads; Papoose w/o PO front;'/ pad
Device Recall Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom)
  • Modelo / Serial
    The hydraulic jack assemblies (Part numbers: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) used as service parts on Stretchers assembled from 8/28/15 - 8/29/15
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in DC and the states of AL, CA, FL, MN, MT, NC, NE, NY, PA, RI, TN, TX, UT, and WV.
  • Descripción del producto
    Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom) || Powered stretcher
  • Manufacturer
    Stryker Medical Division of Stryker Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom)
Device Recall Acorn Stairlifts
  • Modelo / Serial
    Serial Numbers: 140401487591 to 140410249946. All models manufactured before April 2012
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) Distribution to the states of : AL, AZ, CA, CO, DE, FL, GA, IL, IN, KS, KY, LA, MA, ME, MD, MI, MO, NH, NJ, NY, NC, OH, PA, RI, SC, TN, TX, UT, VT, VI, WA, WV, WI, and District of Columbia and to the countries of UK and Germany.
  • Descripción del producto
    Acorn 180 Curved Stairlift
  • Manufacturer
    Acorn Stairlifts Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Acorn Stairlifts
Device Recall AdTech Electrode Connection System/Cables
  • Modelo / Serial
    Lot Numbers: 208140507, 208140552, 208140556, 208140559, 208140560, 208140561, 208140562, 208140563, 208140564R, 208140579, 208140581, 208140586, 208140588R, 208140590, 208140604.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in the states of GA and MI, and the countries of FRANCE, UNITED KINGDOM, COLOMBIA, and BRAZIL.
  • Descripción del producto
    Ad-Tech Electrode Connection System/Cables. Lightweight TECH-ATTACH Cable Models: || 1. L-DCL-4DINX (4 contacts: 1 terminal block with 4 connectors each); || 2. L-DCL-6DINX (6 contacts: 1 terminal block with 6 connectors each); || 3. L-DCL-8DINX (8 contacts: 1 terminal block with 8 connectors each); || 4. L-DCL-16BDINX (16 contacts: 1 terminal block with 16 connectors each); || 5. L-DCL-32BDINX (32 contacts: 2 terminal blocks with 16 connectors each); || 6. L-DCL-64BDINX (64 contacts: 4 terminal blocks with 16 connectors each). || FO TECH-ATTACH Connection Cable model FO-LDC-4DINX (4 contacts: 1 terminal block with 4 connectors each). || Tech-Attach: these cables require the use of an additional component - the connector block. The tail of the electrode is inserted into the block and the block in turn mates with the cable. A key-pin is used to ensure proper orientation. The cable terminated in EEG compatible connector sockets. || Lightweight CABRIO Cable, model L-SRL-64BDINX (64 contacts: 4 terminal blocks with 16 connectors each). Cabrio cables are similar to Tech-Attach cables except that the block portion is pre-attached. The tail of an electrode is inserted into this portion which then hinges shut.
  • Manufacturer
    Ad-Tech Medical Instrument Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall AdTech Electrode Connection System/Cables
Device Recall reVive Light Therapy Pain Relief Device
  • Modelo / Serial
    Manufactured between 12/15/2015 and 12/28/2015 for specific lot #1052
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed to 1 consignee located in the United States.
  • Descripción del producto
    reVive Light Therapy Pain Relief Device (Model Number: RVPNSYS) || Product Usage: || The reVive Light Therapy Pain Relief Device is a device designed to deliver LED light spectrum in 880nm and 660nm directly into the body tissue to increase circulation and temporarily relieve pain associated with muscle spasms, arthritis, general aches and strains.
  • Manufacturer
    LED Technologies, LLC
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall reVive Light Therapy Pain Relief Device
Device Recall Aluminum crutch
  • Modelo / Serial
    Item #.: 1) 10400-1, 2) 10400-8, 3) 10401-1, 4) 10401-8, 5) 10402-1 & 6) 10402-8
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Aluminum crutch under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum crutch, adult, 8 pairs per case, 3) Aluminum crutch, youth, 1 pair per case, 4) Aluminum crutch 8 pairs per case, 5) Aluminum crutch, tall adult, 1 pair per case & 6) Aluminum crutch, tall adult, 8 pairs per case
  • Manufacturer
    Medical Depot Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Aluminum crutch
Device Recall EZ adjust aluminum crutch
  • Modelo / Serial
    Item #: 1) 10430-1, 2) 10430-8, 3) 10431-1, 4) 10431-8, 5) 10432-1 & 6) 10432-8
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    EZ adjust aluminum crutch under the following labels: 1) EZ adjust aluminum crutch, adult, 1 pair per case, 2) EZ adjust aluminum crutch, adult, 8 pairs per case, 3) EZ adjust aluminum crutch, youth, 1 pair per case, 4) EZ adjust aluminum crutch, youth, 8 pairs per case, 5) EZ adjust aluminum crutch, tall adult, 1 pair per case & 6) EZ adjust aluminum crutch, tall adult, 8 pairs per case
  • Manufacturer
    Medical Depot Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall EZ adjust aluminum crutch
Device Recall Universal aluminum crutch
  • Modelo / Serial
    Item #: RTL 10433
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Universal aluminum crutch, 1 pair per case || Aid the user in walking while relieving weight from one foot or leg.
  • Manufacturer
    Medical Depot Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Universal aluminum crutch
Device Recall Universal Quick Adjust
  • Modelo / Serial
    Item #: 1) RTL 10400, 2) RTL 10402
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum crutch, tall adult, 1 pair per case || Aid the user in walking while relieving weight from one foot or leg.
  • Manufacturer
    Medical Depot Inc.
  • 2 Events
    • Retiro De Equipo (Recall) de Device Recall Universal Quick Adjust
    • Retiro De Equipo (Recall) de Device Recall Universal Quick Adjust
Device Recall Direct Supply aluminum crutch
  • Modelo / Serial
    Item #: DS 10400
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Direct Supply aluminum crutch, adult, 1 pair per case || Aid the user in walking while relieving weight from one foot or leg.
  • Manufacturer
    Medical Depot Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Direct Supply aluminum crutch
Device Recall HeaterBaum Foot & Ankle Heating Pad
  • Modelo / Serial
    All lots; UPC: 862821000030.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US, including the states of AL, AR, CA, FL, GA, KS, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, PA, TN, TX, UT, VA, and WA; and, the countries of Ecuador & Venezuela.
  • Descripción del producto
    HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC Adapter.
  • Manufacturer
    Ergoactives, Llc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall HeaterBaum Foot & Ankle Heating Pad
Device Recall Quickie Q7 wheelchair. Model EIR4
  • Modelo / Serial
    Model EIR 4 13,000 + serial numbers. RES would not accept this number. Please see spreadsheet provided in documents.R4-007239 to R4-022394. Serial number range:
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US and Mexico, Japan, Chile, Kuwait, Columbia, Hong Kong, China, Uruguay, South Africa, Costa Rica, South Korea, Singapore, New Zealand, El Salvador, Bahrain, Uruguay, Lebanon, United Arab Emirates, Brazil, Argentina, Netherlands Antilles, British Virgin Islands,
  • Descripción del producto
    Quickie Q7 wheelchair. Model EIR4 || Physical Medicine. || The Quickie Q7 series of wheelchair's intended use is to provide mobility to persons limited to a sitting position.
  • Manufacturer
    Sunrise Medical (US) LLC
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Quickie Q7 wheelchair. Model EIR4
Device Recall Journey Rolling Walker
  • Modelo / Serial
    Serial No. YA 4205RDFG004 TO YA4205RDFG0098 YZ4205BKFC0002 TO YZ4205RDFE0100
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the states of: CA, IN, HI, CT, UT, WA, FL, VA, WI, OH, MN, KS, MD, IL, MO, WY, MT, ME, PA, TN, MI, OR, NY, NJ, ID, NC, IA, OK, AR, VT, SC, TX
  • Descripción del producto
    4205 Journey Rolling Walker || Product Usage: used to assist people in walking
  • Manufacturer
    Nova Ortho-Med Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Journey Rolling Walker
Device Recall TENNIS ELBOW SUPPORT
  • Modelo / Serial
    Lots: 42249787, 42490802, 42737908, 42944296, 43000801, 43031421, 43036118, 43068890, 43134851, 4363109, and 43454441
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only, || Product Usage: || Lateral and medial epicondylitis
  • Manufacturer
    DeRoyal Industries Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall TENNIS ELBOW SUPPORT
Device Recall TENNIS ELBOW SUPPORT
  • Modelo / Serial
    Lots: 47001, 49894, and 51311
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only, || Product Usage: || Lateral and medial epicondylitis
  • Manufacturer
    DeRoyal Industries Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall TENNIS ELBOW SUPPORT
Device Recall TRUBalance3 Power Positioning System
  • Modelo / Serial
    Numerous serial numbers affected (12,343 units)
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). || Mobility Medical Device
  • Manufacturer
    Pride Mobility Products Corp
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall TRUBalance3 Power Positioning System
Device Recall Arial WaterResistant Pendant, model 59350
  • Modelo / Serial
    Serial numbers WP149149 through WP149398 and WP149649 through WP149898.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to AR, AZ, CA, FL, GA, IA, ID, IN, KS, MD, MN, MO, NC, NE, NJ, NY, OH, OR, PA, SD, UT, VA, and WI.
  • Descripción del producto
    Arial Wireless Water-Resistant Call Pendant || The Arial Pendant tag is part of the Arial wireless emergency call management system. It enables residents in assisted living, skilled nursing or independent living to call staff with the press of a button.
  • Manufacturer
    Stanley Security Solutions Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Arial WaterResistant Pendant, model 59350
Device Recall Hidrex USA DP450
  • Modelo / Serial
    SN# 16-3.7091 to 16-3.7134, 17-3.7001 to 17-3.7020
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide throughout the US
  • Descripción del producto
    Hidrex USA DP450
  • Manufacturer
    Hidrex GmbH
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Hidrex USA DP450
Device Recall Hidrex USA DVP1000
  • Modelo / Serial
    SN# 16-3.6190 to 16-3.6319, 17-3.6001 to 17-3.6050
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide throughout the US
  • Descripción del producto
    Hidrex USA DVP1000
  • Manufacturer
    Hidrex GmbH
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Hidrex USA DVP1000
Device Recall Daavlin Aquex (DAAV1000)
  • Modelo / Serial
    SN# 16-3.8001 to 16-3.8250
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide throughout the US
  • Descripción del producto
    Daavlin Aquex (DAAV1000)
  • Manufacturer
    Hidrex GmbH
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Daavlin Aquex (DAAV1000)
Device Recall ROHO HIGH PROFILE Single Compartment Cushion
  • Modelo / Serial
    Serial Numbers: A2920163 through A3185287 Model Numbers: 1R1010H-CA-SC, 1R109M-CA-SR, 1R1211H-CH-SR, 1R88H-CA-SR, 1R1010H-CA-SCDM, 1R109M-CF-SR, 1R1212H-CA-SR, 1R88H-CF-SR, 1R1010H-CA-SR, 1R109M-CH-SR, 1R1212H-CH-SR, 1R88H-CH-SR, 1R1010H-CF-SCDM, 1R1110H-CA-SC, 1R129H-CA-SR, 1R88M-CA-SR, 1R1010H-CF-SR, 1R1110H-CA-SR, 1R1310H-CA-SR, 1R88M-CF-SR, 1R1010H-CH-SR, 1R1110H-CF-SR, 1R1310H-CF-SR, 1R89H-CA-SR, 1R1010M-CA-SC, 1R1110H-CH-SC, 1R1311H-CA-SR, 1R89H-CF-SR, 1R1010M-CA-SCDM, 1R1110H-CH-SR, 1R1311H-CH-SR, 1R89M-CA-SR, 1R1010M-CA-SR, 1R1110M-CA-SR, 1R1411H-CA-SR, 1R89M-CF-SR, 1R1010M-CF-SCDM, 1R1110M-CF-SR, 1R1411H-CF-SR, 1R910H-CA-SR, 1R1010M-CF-SR, 1R1110M-CH-SC, 1R1511H-CA-SR, 1R910H-CF-SR, 1R1010M-CH-SR, 1R1110M-CH-SR, 1R66H-CA-SR, 1R910H-CH-SC, 1R1011H-CA-SC, 1R1111H-CA-SC, 1R66H-CF-SR, 1R910H-CH-SR, 1R1011H-CA-SR, 1R1111H-CA-SR, 1R67H-CF-SR, 1R910M-CA-SR, 1R1011H-CF-SR, 1R1111H-CF-SR, 1R77H-CA-SR, 1R910M-CF-SR, 1R1011H-CH-SC, 1R1111H-CH-SC, 1R77H-CF-SR, 1R911H-CA-SC, 1R1011H-CH-SR, 1R1111H-CH-SR, 1R77M-CA-SR, 1R911H-CA-SR, 1R1011M-CA-SC, 1R1111M-CA-SR, 1R77M-CF-SR, 1R911H-CF-SR, 1R1011M-CA-SR, 1R1111M-CF-SR, 1R78H-CA-SR, 1R911H-CH-SR, 1R1011M-CF-SR, 1R1111M-CH-SR, 1R78H-CF-SR, 1R98H-CA-SR, 1R1012H-CA-SR, 1R1112H-CA-SR, 1R78M-CA-SR, 1R98H-CF-SR, 1R1012H-CF-SR, 1R1112H-CF-SR, 1R78M-CF-SR, 1R99H-CA-SC, 1R1012H-CH-SR, 1R1112H-CH-SR, 1R79H-CA-SR, 1R99H-CA-SCDM, 1R108H-CA-SR, 1R119H-CA-SC, 1R79H-CF-SR, 1R99H-CA-SR, 1R108H-CF-SR, 1R119H-CA-SR, 1R810H-CA-SR, 1R99H-CF-SCDM, 1R109H-CA-SCDM, 1R119H-CF-SR, 1R810H-CF-SR, 1R99H-CF-SR, 1R109H-CA-SR, 1R1210H-CA-SC, 1R810M-CA-SR, 1R99H-CH-SR, 1R109H-CF-SCDM, 1R1210H-CA-SR, 1R87H-CA-SC, 1R99M-CA-SR, 1R109H-CF-SR, 1R1210H-CF-SR, 1R87H-CA-SR, 1R99M-CF-SR, 1R109H-CH-SC, 1R1210H-CH-SR, 1R87H-CF-SR, 1R99M-CH-SR, 1R109H-CH-SR, 1R1211H-CA-SR
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide, Sweden, Germany, New Zealand, Finland, Australia, Singapore, Korea, Luxembourg, Czech Republic, South Africa, Canada, Switzerland, United Arab Emirates, Spain, Austria, Hong Kong, Iceland, Japan, Canada, Italy, Ireland, France, United Kingdom
  • Descripción del producto
    ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID PROFILE Single Compartment Cushion with Sensor Ready Technology.
  • Manufacturer
    Roho Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ROHO HIGH PROFILE Single Compartment Cushion
Device Recall ATAR eusable Extension Cables
  • Modelo / Serial
    Model Code (Lot #): 53912 - MDTS ATAR REUSABLE (D2-02245 D2-02269 D2-02304 D2-02310 OR-04362 D2-02459 D2-02487 D2 02622 D2-02669 D2-02683 D2-02734 D2-02684 D2-02773 D2-02795 D2-02853 D2-02854 D2-02852 D2-02947 D2-02946 D2-02945 OR-04680 D2-03029 D2-02953 D2-03050 D2-03107 OR-04694 D2-03059 D2-03058 D2 03050 OR-04693 D2-03161 D2-03201 D2-03186 D2-03236 D2-03607 D2-03798 D2-03877 D2-03763 D2-03797 D2-03774 D2-03545 D2-03546 D2-03547 D2-03554 D2-03568 D2-03570 D2-03799 D2-03606 D2-03800 D2-03627 D2-03626 D2-03729 D2-03730 D2-03731 D2-03732 D2-03755 D2-03756 D2-03757 D2-03758 D2-03761 D2-03762 D2-03571 D2-03867 D2-03777 D2-03884 D2-03882 D2-03783 D2-03883 D2-03899 D2-03880 D2-03898 D2-03782 D2-03878 D2-03879 D2-03778 D2-03779 D2-03781 D2-03908 D2-03780 D2-03902 D2-03906 D2-03907 D2-03905 D2-03942 D2-03912 D2-03999 D2-04001 D2-03913 D2-02622), 53912A - MDTS ATAR REUSABLE, ATAR MDTS REUSABLE (D2-01835 D2-02144 D2-02304 D2-02621 D2-02773 D2-02795 D2-03058 D2-02765 D2-03290 D2-03204 D2-03185 D2-03184 D2-03236 D2-03443 D2-02551 D2-02749 D2-03161 D2-02683 D2-02948 D2-03544 D2-02269 OR-04362 D2-02459 D2-02245 D2-03881 D2-01821 D2-03203 D2-03237 D2-03446 D2-03911 DP-02832 D2 02538 DP-03150 OR-04694 D2-03150 D2-03148 D2-03152 D2-03059 D2-03151 D2-03543 D2-03221 D2 03290 D2-03287 D2-03202 D2 03543 D2-03445 D2-03757 D2-03777 D2-03899 D2-03878 D2-03912 D2-03914), ATAR-A DARK BLUE REUSABLE (D2-02776 D2-03741 D2-01574 D8-00030 D2-01779 D8-00011 D2-01779 00 D2-02389 D2 02389 D2-03176 D2-03092 D2-03334 D2-03040 D2-01764 DP-02398 D2-02349 D2-02369 D2-03574 D2 03334 D2-03691 D2-03964 D8-00011-00 D2-02076 D2-02194 D2-03695 D2 01779 D2-01493 D2 02076 D2-02535 D2-03639 D2 01938 D2-01938 00 D2-02503 D2-01938 D2-02359 C1-06065 D2-01654 D2 01714 OR-03910 D2-02109 D2-02526 D2-03600 D2-03629 D2-03652 D2-02824 D2-02398 D2-02468 D2-01679 D2-02937 D2 02468 D2 02503 OR-04391 D2- 02503 D2-02476 OR-04393 D2-01714 D2-01714-0 D2 01779-00 D2 01714-00 D2 02194 OR-04118 D2-03864 D2-01722 D2-02136), ATAR-MDT REUSABLE (D2-02766 D2-02514. D2-02933 D2-02949 D2-02950 D2 02514 D2-02537 D2-03576 D2-02987 D2-02366 D2-02431 D202537 D2-02906 OR-03644 D2-01837 D2-02514 DP-02933 DP-02949 D2 02986 OR-03498 OR-03499 D2-01807 D2-01832 OR-03921 D2-02055 D2-01837. D2 01837 OR-04361 D2-02111 D2-02598 D2 02537 D2 02766 D2-02986 D2-04033 D2-03982), ATAR-MDT2 REUSABLE (D2-02583 D2-02336 D2-01797 D2-03768 D2-03523 D2-02541 D2-03512 D2-03651 D2-03748 D2-03769 D2-02582 D2-03955), ATAR-MDT2S-A DK BLUE 30CM REUSABLE (C1-08831 D2-04131), ATAR-MDT2S-V WHITE 30CM REUSABLE (C1-08830 D2-04002), ATAR-MDTL REUSABLE (D8-00005 D2-01352-00), ATAR-MDTR REUSABLE (D2-02210 D2 02211 D2-02833 D2-02211), ATAR-R REUSABLE (D2-03922 D2-01665), ATAR-R T4P REUSABLE (D2-03560), ATAR-R1 REUSABLE (D2-03022 D2-03603 DP-02660 EN-11196 OR-04350 D2-01763 OR-03790 D2 03022 D2-04208 D2-02770 D2-02778 D2-02660), ATAR-RL REUSABLE (D8-00026 D2-01846 D8-00025 D2-02057 D2-01677 D2-02142 D2-03689 D2-03744 D2 03744 D2-03578 D2-04012 OR-03967 D2-02396), ATAR-T REUSABLE (D2-03078 D2 02140 D2-02465 D2-02580 D2 02515 D2-02928 D2-03292 D2-02515 D2-04152 D2-03653 D2-03954 D2-02929 D2 03726 D2 02140. D2-02056 D2-01836 D2-03726 D2-01796 D2-0256 D2-02140 D2-02140. D202140 D2.02140 D2 02580 D2-02772 D2-03575 D2-02963 D2-03726. D2-04013 D2 04152 D2-04247 OR-03975 D2-01016-01 D2-01016-02), ATAR-V WHITE REUSABLE (D2-02588 D2-03857 D8-00012 D2 01780 D8 00012 D2-02350 D2 02302 D2-03174 D2-03305 D2-03034 D2-03055 D2-03093 D2-03696 D2-01680 OR-03909 D2 02137 D2-02536 D2-02025 D2-01780 00 DP-02904 D2-02464 D2-03036 D2-01780 D2 01575 D2-02506 D2-02137 D2-02302 D2-03789 D2-02110 D2-01575 D2-03605 D2-03640 D202764 D2-03956 D2-01715 D2 02350 D2-02764 D2-01488 D2-02467 D8-00012-00 D8-00031 D2-01655 D2 01715 D2-02137. D2-02488 D2-03452 D2-03597 D2-03562 D2-03630 DOR01003 OR-04438 D2 02536 D2 02764 D2-02904 D2-03035 D2-03692 D2-03693), ATAR-V2 REUSABLE (D2-02787 D2-02647), XI.A DARK BLUE REUSABLE (D2-01938 DP-01001 D2-02136 D2-02358 D2-02398 D2-02441 D2-02476 EG-01326 EG 01326 EG-01369 D2-03062), XI.MDT REUSABLE (D2-02055 D2-02364 D2-02480 D2-02450 OR-04361 D2-02514 D2-02451 D2-02860 D2-02867 D2 02364 D2-02772 D2 02867 D2-02906 D2-02868 D2-02964 D2-03329 D2 03329 D2-03575 D2-03501 D2-02986 D2 02964 D2-03860 D2-03982 D2-04090 D2 04090 D2-04120), XI.R REUSABLE (D2-01665 D2-02141 D2-02423 D2-02449 D2-02486), XI.V WHITE (DP-01024 D2-02248 DP 01024 D2-02302 D2-02359 D2 02248 D2-02350 D2-02395 D2-02452 D2-02577 EG-01328 EG-01328 EG-01328 D2-03063)
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -US to AL, AK, CA, CO, FL, GA, ID, IL, IN, IA , KS, KY, ME, MD, MA, MI, MN, MO, MT, NE, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, WI, DC. Foreign distribution to following countries: Macedonia, Pakistan, Austria, Canada, Guatemala, United Kingdom, Republic of Panama, Chile, Aruba, Saudi Arabia, Kuwait, Costa Rica, Albania, Estonia, New Zealand, Germany, Puerto Rico, Turkey, Virgin Islands, Iraq, Hong Kong, and Morocco,
  • Descripción del producto
    ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. || Model codes: 53912 - MDTS ATAR REUSABLE, 53912A - MDTS ATAR REUSABLE, ATAR MDTS REUSABLE, ATAR-A DARK BLUE REUSABLE, ATAR-MDT REUSABLE, ATAR-MDT2 REUSABLE, ATAR-MDT2S-A, DK BLUE 30CM REUSABLE, ATAR-MDT2S-V WHITE 30CM REUSABLE, ATAR-MDTL REUSABLE, ATAR-MDTR REUSABLE, ATAR-R REUSABLE, ATAR-R T4P REUSABLE, ATAR-R1 REUSABLE, ATAR-RL REUSABLE, ATAR-T REUSABLE, ATAR-V WHITE REUSABLE, ATAR-V2 REUSABLE, XI.A DARK BLUE REUSABLE, XI.MDT REUSABLE, XI.R REUSABLE, XI.V WHITE, REUSEABLE || Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker
  • Manufacturer
    Oscor, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ATAR eusable Extension Cables
Device Recall ROTH MOBELI
  • Modelo / Serial
    ROTH Catalogue Numbers 14002 96 S and 14002 25 S only.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : Pennsylvania, Massachusetts, Minnesota, Alabama, Michigan, Texas and Washington.
  • Descripción del producto
    ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number 14002 96 S, EOS Imaging Catalogue Number 9000111773; and MOBELI Dual Grip Grab Handle, ROTH Catalogue Number 14002 25 S, EOS Imaging Catalogue Number 9000111774.
  • Manufacturer
    EOS Imaging
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ROTH MOBELI
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