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  • Dispositivo 500
  • Fabricante 31827
  • Evento 523
  • Implante 1
Device Recall Shower Seat, Nonrotating
  • Modelo / Serial
    Device is not identified with a lot code. Inventories received between May 1, 2009 and July 7, 2009 are being recalled.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA and Canada.
  • Descripción del producto
    Shower Seat, Non-rotating, Catalog number 727152000
  • Manufacturer
    Nutech Manufacturing Corp
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Shower Seat, Nonrotating
Device Recall Shower Seat, Rotating
  • Modelo / Serial
    Device is not identified with a lot code. Inventories received between May 1, 2009 and July 7, 2009 are being recalled.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA and Canada.
  • Descripción del producto
    Shower Seat, Rotating, Catalog number 727152100
  • Manufacturer
    Nutech Manufacturing Corp
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Shower Seat, Rotating
Device Recall AC Power Cords
  • Modelo / Serial
    Device serial numbers affected: Kinair IV: KAPK00523 - KAPK00691; Kinair IV 60601: KAUK00001 - KAUK00134; Triadyne Proventa: TDDK0001 - TDDK00367; Therapulse ATP: TPNK00001 - TPNK00177; Kinair Medsurg: 1440-1441, KAS01524, KASK01004 - KASK02930; and Kinair Medsurg Pulse: KATK00001 - KATK00655
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and Canada
  • Descripción del producto
    AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #4100079 used with Kinair IV Model 22600, Kinair IV 60601 Model 216050, Triadyne Proventa Model 406000, Therapulse ATP/II Models 227800 and 227080.S, Kinair Medsurg Model 201001W, and Kinair Medsurg Pulse Model 40900.
  • Manufacturer
    KCI USA, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall AC Power Cords
Device Recall AC Power Cords
  • Modelo / Serial
    Device Serial Numbers Affected: Tricell 60601 - Serial Numbers FSUK00011-FSUK01400; used with First Step Select - Serial Numbers FWSK00001-FSWK02393; and used with Plexipulse - Serial Numbers PPGK00001-PPGK00226.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and Canada
  • Descripción del producto
    AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #4102204 used with Tricell 60601 Model 212857, First Step Select Model 215200 , and Plexipulse Model 205835.
  • Manufacturer
    KCI USA, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall AC Power Cords
Device Recall TempPad Cold Therapy Pad .
  • Modelo / Serial
    Part #: 50625, Catalog number: 510-US, Lot #: 08296, 08529, 08530, 08531, 08674, 08759, 08826, 08952, 09052, 09166, 09422, 09423; Part #: 50633, Catalog #: 510-USS, Lot #: 08537, 08675, 08953; Part #: 50627, Catalog #: 814-US, Lot #: 08610; Part # 50634, Catalog # 814-USS, Lot #: 08611, 08919, 09466; Part #: 50628, Catalog #: 1112-US, Lot #'s: 08382, 08411, 08475, 08476, 08477, 08557, 08583, 08657, 08666, 08667, 09486, 08668, 08707, 08771, 08810, 08874, 08903, 08971, 09037, 09088, 09089, 09149, 09225, 09251, 09285, 09313, 09314, 09327, 09360, 09361, 08320; Part #:50635, Catalog #: 1112-USS, Lot #'s: 08410, 08514, 08606, 08673, 08708, 08772, 08802, 08868, 08954, 09017, 09066, 09067, 09195, 09253, 09254, 09295, 09377, 09378, 09485, 08331; Part #: 50629, Catalog #: 1215-US, Lot #'s: 08395, 08584, 08669, 08732, 08917, 08989, 09107, 09218 & Part #: 50137, and Catalog #: CT-99, Lot #'s: 08332, 08353, 08438, 08538, 08607, 08608, 08706, 08725, 08773, 08837, 08851, 08879, 08933, 08970, 09010, 09086, 09087, 09143, 09144, 09157, 09294, 09329, 09362, 09379 and 08423.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- United States (AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI & WV), Canada, France, Germany, Ireland, Israel, New Zealand, Singapore, and The Netherlands.
  • Descripción del producto
    TempPad¿ Cold Therapy Pad. || The device is used for localized temperature therapy including hand, elbow, arm, foot, ankle, leg, or knee.
  • Manufacturer
    Cincinnati Sub-Zero Products Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall TempPad Cold Therapy Pad .
Device Recall Pressure Imaging System
  • Modelo / Serial
    Serial numbers for X3 display: CTDPDA00 S2000 R04, CTDPDA00 S2001 R04, CTDPDA00 S2002 R04, CTDPDA00 S2003 R04, CTDPDA00 S2004 R04, CTDPDA00 S2005 R04, CTDPDA00 S2006 R04, CTDPDA00 S2007 R04, CTDPDA00 S2013 R04, CTDPDA00 S2016 R04, CTDPDA00 S2017 R04, CTDPDA00 S2021 R04, CTDPDA00 S2022 R04, CTDPDA00 S2024 R04, CTDPDA00 S2025 R04, CTDPDA00 S2026 R04, CTDPDA00 S2027 R04, CTDPDA00 S2028 R04, CTDPDA00 S2030 R04, CTDPDA00 S2032 R04, CTDPDA00 S2035 R05, CTDPDA00 S2036 R05, CTDPDA00 S2037 R05, CTDPDA00 S2038 R05, CTDPDA00 S2039 R05, CTDPDA00 S2040 R05, CTDPDA00 S2041 R05, CTDPDA00 S2042 R05, CTDPDA00 S2043 R05, CTDPDA00 S2044 R05, CTDPDA00 S2045 R05, CTDPDA00 S2050 R05, and CTDPDA00 S2054 R05.   Serial numbers for X3 PRO: CMUHUB00 S2023 R05 and CMUHUB00 S2033 R05.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Devices were distributed to one distributor, medical facilities, and rehab centers through out the US, including following states: AL, AR, AZ, CA, CO, FL, GA, IA, IL, KS, ME, MI, MN, MO, NC, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, and WI.
  • Descripción del producto
    Product labeling of the X3 Display reads in part: || "XSENSOR Technology Corporation***X3 DISPLAY*** REF: XBOM-002 PID: CTDPDA00 S*** R***60601-1 61010-1***Calgary, AB, CANADA***Made in Canada". || Product labeling of the X3 PRO reads in part: || "XSENSOR Technology Corporation***X3 PRO***REF:XBOM-004 PID: CMUHUB00 S***R***60601-1 61010-1***Calgary, AB, CANADA***Made in Canada". || Pressure mapping and surface assessment for seats, seat backs, and beds. XSENSOR pressure imaging systems, also known as pressure mapping systems, are a valuable tool in helping clinicians prevent and manage pressure ulcers. Clinicians, nurses, and rehabilitation specialists use XSENSOR pressure imaging systems to help prevent pressure ulcers through improved surface selection and patient positioning on wheelchairs and hospital beds.
  • Manufacturer
    Xsensor Technology Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Pressure Imaging System
Device Recall Jazzy Select with XLR Port Harness
  • Modelo / Serial
    all serial numbers
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The product was shipped to dealers nationwide who further shipped the product to end users. The product was also shipped to distributors in Canada, Australia and United Kingdom
  • Descripción del producto
    Jazzy Select with XLR Port Harness
  • Manufacturer
    Pride Mobility Products Corp
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Jazzy Select with XLR Port Harness
Device Recall Jazzy Select 6 with XLR Port Harness
  • Modelo / Serial
    all serial numbers
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The product was shipped to dealers nationwide who further shipped the product to end users. The product was also shipped to distributors in Canada, Australia and United Kingdom
  • Descripción del producto
    Jazzy Select 6 with XLR Port Harness
  • Manufacturer
    Pride Mobility Products Corp
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Jazzy Select 6 with XLR Port Harness
Device Recall INDEPENDENCE iBOT 4000 Mobility System
  • Modelo / Serial
    Serial Numbers 020605-001001 to 021007-001451 with Battery Pack(s) Revision 2.0. Serial number contains the month/year of manufacture followed by a sequential number.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and to the United Kingdom.
  • Descripción del producto
    iBOT 4000 Mobility System Battery pack.
  • Manufacturer
    Independence Technology LLC
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall INDEPENDENCE iBOT 4000 Mobility System
Device Recall ENDURANCE HD
  • Modelo / Serial
    All SS Numbers 05F0002740 to RPN090702497.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    ESSENTIAL MEDICAL SUPPLY, INC. ENDURANCE HD, BUILT TO LAST, HEAVY DUTY FOUR WHEEL WALKER for users up to 500 pounds. || Model W1801B- Blue, UPC 7 54756 91802 6 all serial numbers. || W1801R-Red, UPC 7 54756 91803 3 all serial numbers. || The Endurance HD is a four wheeled steel frame walker with loop locking wheel locks, a padded seat and an under seat tote for carrying personal articles. || Used to assist in ambulation and specifically for obese patients weighing up to 500 pounds. || Warranty Card: "...lifetime of the original purchaser...". Usable life of a walker is 5 years but firm will warranty for lifetime of the original purchaser.
  • Manufacturer
    Essential Medical Supply, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ENDURANCE HD
Stryker Atlas Transport Stretcher with Zoom, Model 660Z, Stryker Medical, Portage, MI
  • Modelo / Serial
    Model 660: 61 Units 0310049177, 0310053217, 0311058059, 0311058061, 0311058276, 0311058277, 0311058390, 0311058416, 0311058474, 0312050566, 0312050567, 0312050568, 0407059003, 0407059042, 0407059043, 0407059281, 0407059702, 0408059256, 0408059257, 0408059393, 0409062551, 0409062552, 0409062553, 0409062554, 0409062649, 0409062650, 0409062858, 0409062934, 0409064021, 0409064022, 0409064023, 0409064024, 0409064025, 0409064026, 0409064027, 0409064028, 0409064029, 0409064030, 0409064031, 0409064032, 0409064033, 0409064034, 0409064035, 0409064067, 0409064086, 0409064102, 0409064151, 0409064152, 0409064211, 0409064212, 0409064213, 0409064214, 0409064215, 0409064216, 0409064221, 0409064222, 0409064223, 0409064224, 0409064225, 0409064260, and 0410061720.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, Canada, Brazil, Japan, Singapore, Spain, and the Far East.
  • Descripción del producto
    Stryker Atlas Transport Stretcher with Zoom, Model 660Z, Stryker Medical, Portage, MI
  • Manufacturer
    Stryker Medical Div. of Stryker Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Stryker Atlas Transport Stretcher with Zoom, Model 660Z, Stryker Medical, Portage, MI
Device Recall Stryker MSeries Stretcher
  • Modelo / Serial
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, Canada, Brazil, Japan, Singapore, Spain, and the Far East.
  • Descripción del producto
    Stryker M-Series Stretcher, Model 1025 (SM304), Stryker Medical, Portage, MI.
  • Manufacturer
    Stryker Medical Div. of Stryker Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Stryker MSeries Stretcher
Device Recall Stryker Renaissance Series Stretchers
  • Modelo / Serial
    Model 1231: 39 Units 0310049178, 0310049179, 0311058120, 0312050809, 0407059532, 0407059533, 0407059656, 0407059657, 0407059851, 0407059852, 0407059853, 0407059854, 0407059855, 0407059856, 0407059857, 0407059858, 0407059859, 0407059860, 0407059861, 0407059862, 0407059863, 0407059864, 0407059865, 0407059866, 0407059867, 0407059868, 0407059869, 0407059870, 0408059073, 0408059123, 0408059124, 0408059871, 0408059872, 0408059873, 0408059874, 0408059875, 0408059876, 0408059877, and 0409062555.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, Canada, Brazil, Japan, Singapore, Spain, and the Far East.
  • Descripción del producto
    Stryker Renaissance Series Stretchers, Model 1231Z Emergency Care with Zoom, Stryker Medical, Portage, MI.
  • Manufacturer
    Stryker Medical Div. of Stryker Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Stryker Renaissance Series Stretchers
Device Recall Stryker Renaissance Series Stretchers
  • Modelo / Serial
    Model 1731: 19 Units 0306055261, 0306055262, 0311054605, 0311054606, 0311058060, 0311058130, 0311058491, 0311058492, 0312050810, 0406059715, 0406059835, 0406059836, 0406059837, 0407059289, 0407059290, 0407059291, 0409062599, 0409064150, and 0409064258.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, Canada, Brazil, Japan, Singapore, Spain, and the Far East.
  • Descripción del producto
    Stryker Renaissance Series Stretchers, Model 1731Z PACU with Zoom, Stryker Medical, Portage, MI.
  • Manufacturer
    Stryker Medical Div. of Stryker Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Stryker Renaissance Series Stretchers
Device Recall Stryker power cord kits
  • Modelo / Serial
    There are no serial numbers associated with the cord kits.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, Canada, Brazil, Japan, Singapore, Spain, and the Far East.
  • Descripción del producto
    Stryker power cord kits, Stryker Medical, Portage, MI.
  • Manufacturer
    Stryker Medical Div. of Stryker Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Stryker power cord kits
Device Recall RS4i Sequential Stimulator;
  • Modelo / Serial
    Device is labeled as 4i and a unique sequential six-digit number. 4i is specific for RS 4i device and six-digit sequential numbering for device. Serial numbers 4i300000 to 4i467119.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    The device is labeled in part: " RS Medical RS-4i Stimulator". The device is sold in a kit that includes a carrying case, connector cables, pads (electrodes), battery charger, patient document, instructional DVD, return mail bag, and the operation manual. || This device is used with cables and electrodes that are placed on skin in the treatment area, and allow an electrical micro-current to relieve pain. The device requires a prescription from a physician. It is programmed by an RS medical employee (or Account Manager) to the physician's specific treatment plan for each patient. The patient is given instructions on how to utilize the device (proper electrode placement). Powered MUSCLE Stimulation indications for use including: 1) Relax muscle spasm. 2) Prevention or retardation of disuse atrophy. 3) Maintain or increase range of motion. 4) Increase local blood circulation. 5) Re-educate muscle. 6) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. INTERFERENTIAL Stimulation indications for use including: 1) Relieve acute pain. 2) Relieve and manage chronic pain.
  • Manufacturer
    International Rehabilitative Sciences, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall RS4i Sequential Stimulator;
Device Recall Titan XL
  • Modelo / Serial
    All products manufactured before October 1, 2009 with gold plated end blocks.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OK, OR, PA, OH, SC, TN, TX, UT, VA, VT, WA, WI, WV, AND WY and the countries of Argentina, Australia, Austria, Barbados, Belgium, Bermuda, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cypress, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Lle de la Reunion, Mexico, New Zealand, Phillipines, Poland, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, Turkey, UAE, and Ukraine.
  • Descripción del producto
    Titan XL Handpiece Infrared Therapeutic Heating Lamp, Manufactured by Cutera Inc, Brisbane, CA || Infrared therapeutic heating lamp, intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness.
  • Manufacturer
    Cutera Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Titan XL
Device Recall Victory 9 with Power Seat
  • Modelo / Serial
    SC609PS SD514509149FV0 SD514609080FV0 SD514609059FV0 SD514509207FV0 SD514509251FV0 SD514609113FV0 SD514609133FV0 SD514509186FV0 SD514509246FV0 SD520809132FV0 SD514609024FV0 SD514509188FV0 SD514609020FV0 SD502010082030 SD502010080030 SD502010084030 SD514509181FV0 SD514509240FV0 SD514609141FV0 SD514609030FV0 SD525409018030 SD514609005FV0 SD514609007FV0 SD514509194FV0 SD514609119FV0 SD514509222FV0 SD514609135FV0 SD520809138FV0 SD520809037FV0 SD514509211FV0 SD514609009FV0 SD514509197FV0 SD514509164FV0 SD514509223FV0 SD514509195FV0 SD514609067FV0 SD514609034FV0 SD514509210FV0 SD514609081FV0 SD520809048FV0 SD514509171FV0 SD520809076FV0 SD514509153FV0 SD514509156FV0 SD514509160FV0 SD514509231FV0 SD514509250FV0 SD514509157FV0 SD514509151FV0 SD514509150FV0 SD514609112FV0 SD514509169FV0 SD514609106FV0 SD514609087FV0 SD514609116FV0 SD514509176FV0 SD514609120FV0 SD514609013FV0 SD514609118FV0 SD514509274FV0 SD526409032030 SD514609102FV0 SD514609027FV0 SD514609041FV0 SD514609051FV0 SD514609134FV0 SD514509199FV0 SD514609083FV0 SD514609049FV0 SD514609055FV0 SD514609077FV0 SD514509203FV0 SD514509249FV0 SD514509183FV0 SD514509189FV0 SD520809119FV0 SD514609076FV0 SD514509158FV0 SD514509184FV0 SD514609084FV0 SD514509147FV0 SD520809042FV0 SD514509201FV0 SD514609026FV0 SD514509258FV0 SD533509010030 SD514609125FV0 SD514509154FV0 SD514609074FV0 SD514609054FV0 SD514609057FV0 SD520809134FV0 SD514609075FV0 SD514609008FV0 SD514509255FV0 SD514509187FV0 SD514609052FV0 SD514609079FV0 SD514509200FV0 SD514509272FV0 SD514609111FV0 SD514609082FV0 SD514609115FV0 SD514609021FV0 SD514609017FV0 SD514609035FV0 SD514609038FV0 SD514609063FV0 SD514509213FV0 SD514609062FV0 SD514509218FV0 SD514609060FV0 SD514509202FV0 SD514609036FV0 SD514509206FV0 SD514609031FV0 SD514509185FV0 SD514509152FV0 SD514609091FV0 SD514609100FV0 SD514609064FV0 SD514609045FV0 SD514509248FV0 SD514609129FV0 SD514509172FV0 SD514609128FV0 SD514609016FV0 SD514609117FV0 SD514509216FV0 SD514509268FV0 SD514609033FV0 SD514509148FV0 SD514609140FV0 SD520809113FV0 SD514609109FV0 SD514609056FV0 SD502110014030 SD514609122FV0 SD514609043FV0 SD520809136FV0 SD514509196FV0 SD514609078FV0 SD514509205FV0 SD514509243FV0 SD514509275FV0 SD520809041FV0 SD514509229FV0 SD527409028030 SD514609126FV0 SD514609085FV0 SD514609138FV0 SD514609006FV0 SD520809100FV0 SD514609028FV0 SD514609010FV0 SD526509020030 SD526509018030 SD514509271FV0 SD514509177FV0 SD514609061FV0 SD514509198FV0 SD514509266FV0 SD514509232FV0 SD514509233FV0 SD514609094FV0 SD514609073FV0 SD520809081FV0 SD514509182FV0 SD514509242FV0 SD514609086FV0 SD514509190FV0 SD514509212FV0 SD514609105FV0 SD514609023FV0 SD514609029FV0 SD514509173FV0 SD514609002FV0 SD514509204FV0 SD514509170FV0 SD514609107FV0 SD514509238FV0 SD514609019FV0 SD514509163FV0 SD536409020030
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    Victory 9 with Power Seat (SC609PS) || Motorized wheelchair with elevating seat.
  • Manufacturer
    Pride Mobility Products Corp
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Victory 9 with Power Seat
Device Recall Flexicair II
  • Modelo / Serial
    All Serial numbers. The devices have a nomenclature for each respective product model where the serial number is IBxxxxxx, where xxxxxx is a six digit number. The prefix IB is representative of a Flexicair II, prefix IC is representative of a Flexicair MC3 and a six digit number without a prefix is representative of a refurbished Flexicair MC 3.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including CA, FL, GA, IL, MI , MS, NJ, NY, OH and PA
  • Descripción del producto
    Flexicair¿ II (Model number 13000) Low Airloss Therapy Units || For use to prevent pressure sore development and wound deterioration in patients who have significant risk of developing these problems and who generally also have one or more to the following conditions: immobility, incontinence, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue, or multi-system failure.
  • Manufacturer
    Hill-Rom Manufacturing, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Flexicair II
Device Recall Flexicair MC3
  • Modelo / Serial
    All Serial numbers. The devices have a nomenclature for each respective product model where the serial number is IBxxxxxx, where xxxxxx is a six digit number. The prefix IB is representative of a Flexicair II, prefix IC is representative of a Flexicair MC3 and a six digit number without a prefix is representative of a refurbished Flexicair MC 3.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including CA, FL, GA, IL, MI , MS, NJ, NY, OH and PA
  • Descripción del producto
    Flexicair¿ MC3 (Model number: M4000) Low Airloss Therapy Units || For use to prevent pressure sore development and wound deterioration in patients who have significant risk of developing these problems and who generally also have one or more to the following conditions: immobility, incontinence, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue, or multi-system failure.
  • Manufacturer
    Hill-Rom Manufacturing, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Flexicair MC3
Device Recall Ossur Total knee
  • Modelo / Serial
    Serial Numbers (new units):13241, 13243, 13245, 13246, 13247, 13248, 13251, 13252, 13253, 13254, 13255, 13256, 13259, 13260, 13261, 13262, 13263, 13264, 13265, 13266, 13267, 13268, 13269, 13270, 13271, 13272, 13282, 13284, 13285, 13286, 13287, 13289, 13290, 13293, 13296, 13297, 13298, 13300, 13301, 13302, 13304, 13306, 13307, 13308, 13309, 13310, 13311, 13312, 13313, 13314, 13315, 13317, 13318, 13319, 13320, 13321, 13322, 13323, 13324, 13325, 13326, 13327, 13329, 13330, 13331, 13332, 13333, 13334, 13335, 13336, 13337, 13338, 13339, 13340, 13341, 13342, 13344, 13345, 13346, 13347, 13348, 13349, 13350, 13351, 13352, 13353, 13354, 13358, 13360, 13363, 13364, 13365, 13368, 13369, 13370, 13371, 13372, 13373, 13374, 13375, 13376, 13377, 13378, 13379, 13380, 13381, 13384, 13385, 13386, 13387, 13393, 13394, 13395, 13397, 13399, 13400, 13401, 13407, 13409, 13410, 13411, 13412, 13413, 13414, 13415, 13416, 13417, 13418, 13420, 13431  Repairs units: 9611, 10325, 10616, 11615, 11747, 11795, 12091, 12092, 12097, 12098, 12101, 12104
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including CA, CO, FL, LA, MD, MI, MO, NJ, NY, OH, TN, VA,, and WA and the countries of Australia, Canada, Czech Republic, Germany, France, United Kingdom, Ireland, Italy, Japan, The Netherlands, Russian Federation, Sweden and Turkey.
  • Descripción del producto
    Ossur Total Knee, Model Number: 2100 || The Total Knee 2100 is an external prosthetic knee joint. It is a polycentric knee designed for multi-speed ambulators, higher impact levels and heavier loads.
  • Manufacturer
    Ossur Engineering, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Ossur Total knee
Device Recall HealthPort BioAnologics Patient Electrode Sensor Test Kit,
  • Modelo / Serial
    4 lots affected: 198459, Exp. 02-2012; 200026, Exp. 03-2012; 203031, Exp. 08-2012; 204885, Exp. 12-2012
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    OR
  • Descripción del producto
    HealthPort BioAnologics Patient Electrode Sensor Test Kit, Part # SEN-0025-0, 25 kits/carton || Each kit contains 100 tab electrodes and 26 alcohol pads. The electrodes are used to measure bodyfat analysis. The alcohol pads (non-sterile) are used for cleaning the skin to help the electrodes adhere better. There are no instructions for use with the kit.
  • Manufacturer
    Vermed, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall HealthPort BioAnologics Patient Electrode Sensor Test Kit,
Device Recall Accolade TMZF Plus Hip Stem
  • Modelo / Serial
    Catalog @ 3020-0537 Accolated TMZF Hip Stem # 5 Lot #31390203 8 units CAtalog #6020-3535 Accolade 132 Size 3.5 Lot #31446602R 0 units  CAtalog # 6021-0230 Accolade Plus TMZF Hip Stem #2 Lot #31515703 10 units Catalog # 6021-0335 Accolade Plus TMZF Hipe Stem #3 Lot 31586402 10 units Catalog #3021-0435 Accolade TMZF Hipe STem #4 31597205 1 unit CAtalog # 6021-0435 Accolade Plus TMZF Hipe STem #4 Lot #31597206 4 units Catalog #6021-2530 Accolade (127 deg) Size 2.5 Accolade (127 deg) Size 2.5 Lot #31486505 10 units Catalog # 6021-4535 Accolade (127 DEG) Size 4.5 Lot #31850001 1 unit
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Accolade TMZF Plus Hip Stem: || Catalog # 3020-0537 Accolate d TMZF Hip Stem # 5 || Catalog #6020-3535 Accolade 132 Size 3.5 || Catalog # 6021-0230 Accolade Plus TMZF Hip Stem #2 || Catalog # 6021-0335 Accolade Plus TMZF Hip Stem #3 || Catalog #3021-0435 Accolade TMZF Hip Stem #4 || Catalog # 6021-0435 Accolade Plus TMZF Hip Stem #4 || Catalog #6021-2530 Accolade (127 deg) Size 2.5 Accolade (127 deg) Size 2.5 || Catalog # 6021-4535 Accolade (127 DEG) Size 4.5 || K994366; k023105; K032300 || Manufactured by " Stryker Ireland, Carrigtwohill Industrial Estate Carrington County Cork, Ireland || The subject hip stem is a single-use device intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Accolade TMZF Plus Hip Stem
Device Recall KCI RotoProne Critical Care Therapy
  • Modelo / Serial
    Serial numbers: RRFK0036-RRFK00047; RRFK00049-RRFK00115; RRFK00117-RRFK00128; RRFK00141-RRFK00211; RRFK00213-RRFK00233; RRFK00235; RRFK00237-RRRFK00254; RRFK00256-RRFK00261; RRFK00263-RRFK00267; RRFK00269-RRFK00270; RRFK00273-RRFK00280; RRFK00282-RRFK00284; RRFK00287-RRFK00290; and RRJK00002.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA and Kuwait.
  • Descripción del producto
    KCI RotoProne Critical Care Therapy System buckles for securing patient to the surface during proning therapy, Model 209500. || Indicated for treatment and prevention of pulmonary complications.
  • Manufacturer
    KCI USA, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall KCI RotoProne Critical Care Therapy
Device Recall wheeled adult and junior walkers
  • Modelo / Serial
    All 6240-5F and 6240-JR5F wheeled walkers distributed by the firm between 12/15/2010 and 3/4/2011, are subject to recall/correction.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, including Puerto Rico and countries of Canada, Columbia, and Israel.
  • Descripción del producto
    Dual Blue-Release Adult Walkers - Wheeled, and Blue Release Junior Walkers with 5 inch Fixed Wheels, Model Numbers: 6240-5F and 6240-JR5F. The recalled product is packaged four (4) units per shipping box. || Product Usage: The walkers are intended for people who need additional support to maintain balance or stability while walking.
  • Manufacturer
    Invacare Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall wheeled adult and junior walkers
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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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