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  • Dispositivo 152
  • Fabricante 61
  • Evento 124969
  • Implante 0
Cmax Surgical Table
  • Modelo / Serial
    Model #'s: Cmax110, Cmax 220
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA in the following states: AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WV, and in the countries of Australia, Canada, China, Columbia, Dominican Republic, India, Israel, Mexico, New Zealand, Saudi Arabia, Singapore, South Korea and Taiwan.
  • Descripción del producto
    Cmax Surgical Tables, Model #'s: Cmax110, Cmax 220 manufactured by Steris Corporation in Montgomery, AL
  • Manufacturer
    Steris Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Cmax Surgical Table
Device Recall STERIS 4085, 5085 & 5085SRT
  • Modelo / Serial
    Model #: 4085, 5085 & 5085SRT Serial Numbers: 0400710041, 0400710042, 0400710043, 0400710044, 0401510077, 0401510080, 0401510081, 0401510082, 0401510086, 0401510087, 0401510088, 0401510089, 0401510090, 0401510092, 0401910133, 0402010001, 0402010002, 0402010003, 0403210095, 0403210096, 0403210096, 0403210097, 0403210098, 0403610046, 0403610047, 0403610048, 0403610049, 0403610050, 0403610053, 0403610054, 0403610055, 0403610057, 0403610061, 0403610062, 0403610063, 0404610061, 0404610062, 0404610063, 0404610063, 0404610064, 0404610064, 0404610065, 0404610065, 0404610070, 0404610070, 0404610071, 0404610071, 0404610072, 0404610072, 0405410037, 0405410038, 0405410039, 0432709078, 0432709079, 0432709079, 0432709080, 0432709081, 0432709082, 0432709083, 0432709083, 0432709084, 0432709084, 0433609001, 0433609001, 0433609002, 0433609002, 0433609005, 0433609005, 0433609062, 0434309100, 0434309101, 0434309103, 0434809001, 0434809003, 0434809004, 0434809005, 0434809006, 0434809007, 0434809007, 0434809008, 0434809008, 0434809012, 0434809013, 0434809014, 0434809014, 0434809015, 0434809015, 0434809016, 0434809016, 0434809017, 0434809017, 0434809018, 0434809018, 0434809019, 0434809019, 0436309084, 0436309085, 0436509122, 0436509123, 0436509124 & 0436509124.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA, Australia, India, Korea & New Zealand
  • Descripción del producto
    STERIS 4085, 5085 & 5085SRT Surgical Tables
  • Manufacturer
    Steris Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall STERIS 4085, 5085 & 5085SRT
Device Recall Amsco 3085SP Surgical Table
  • Modelo / Serial
    B420702032 to 0402110097
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide including District of Columbia and Puerto Rico and the following countries: American Samoa, Argentina, Australia, Bahrain, Bangladesh, Bermuda, Brazil, Canada, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Germany, Greece, Guam, Hong Kong, India, Indonesia, Israel, Italy, Japa, Jordan, Kazakhstan, Korea, Kuwait, Lebanon , Libya , Malaysia , Mexico, Morocco, New Zealand, Panama, Peru, Philippines , Poland, Portugal, Qatar, Russia, Saudi Arabia , Singapore, South Africa, Spain, Sri Lanka, Taiwan, Thailand, Trinidad and Tobago, Turkey & United Kingdom.
  • Descripción del producto
    A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible general surgical table. || Product Usage: || Product provides a flexible, easy-to-use, articulated posturing of a patient for either general, I.A., or specialized surgical procedures. There are movable components and accessories intended for use during diagnostic examinations or surgical procedures to support and position a patient.
  • Manufacturer
    Steris Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Amsco 3085SP Surgical Table
Device Recall USE PTA 0.014 RX Catheter
  • Modelo / Serial
    All references USE .014RX.  Lot numbers:  1717082810164720 1717082810164720 1717082810164720 1717082810164720 1717082810164720   1717082810164730 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166230   1717101610166250 1717101610166250 1717082810164740 1717101610166250 1717101610166250 1717082810164740 1717101610166250 1717101610166250   1717082810164760 1717101610166240 1717082810164760   1717082810164770 1717082810164770 1717101610166260 1717101610169180 1717101610169180 1717101610169180 1717101610166260 1717101610169180 1717101610166260 1717082810164770 1717101610166260 1718041510177220 1717082810164770 1717101610169180   1717082810164780 1717101610166270 1717082810164780 1717101610166270 1717101610166270   1717101610169190 1717082810164800 1717101610169190 1717101610169190 1717101610169190 1717101610166280   1717082810164810 1717082810164810 1717101610166290 1717082810164810 1717082810164810 1717101610166290 1717101610166290 1717101610166290 1717082810164810 1717082810164810 1717101610166290 1717101610166290 1717101610166290 1717101610166290 1717082810164810 1717101610166290 1717082810164810 1717082810164810 1717082810164810 1717082810164810   1717082810164820 1717082810164820 1717101610166300 1717082810164820 1717101610166300 1717101610166300 1717082810164820 1717101610166300 1717082810164820 1717101610166300 1717082810164820 1717082810164820 1717082810164820 1717101610166300   1717101610166310 1717101610166310 1717101610166310   1717082810164850 1717082810164850 1717101610166320 1717101610166320 1717101610166320 1717101610166320 1717101610166320 1717101610166320 1717101610166320 1717082810164850 1717082810164850   1717082810164860 1717101610166330 1717101610166330 1717101610166330 1717101610166330   1717101610166340 1717101610166340 1717101610166340 1717101610166340 1717101610166340 1717101610166340   1717082810164890 1717082810164890 1717082810164890 1717101610166350 1717101610166350 1717101610166350 1717101610166350 1717101610166350 1717082810164890 1717101610166350 1717101610166350 1717082810164890 1717101610166350 1717101610166350 1717101610166350 1717101610166350 1717101610166350 1717082810164890 1717082810164890   1717082810164900 1717082810164900 1717101610166360 1717101610166360 1717101610166360 1717101610166360 1717101610166360 1717101610166360 1717101610166360 1717101610166360 1717101610166360 1717101610166360   1717082810164750 1717082810164750 1717082810164750 1717082810164750 1717082810164750 1717082810164750 1717082810164750 1717082810164750 1717082810164750 1717082810164750 1717082810164750   1718041510177210   1718010810171540 1718010810171540 1718010810171540 1718010810171540 1718010810171540 1718010810171540 1718010810171540 1718010810171540 1718010810174410 1718010810174410 1718010810171540   1718051310179200 1718010810171550 1718010810171550 1718010810171550 1718010810171550 1718010810171550 1718010810171550 1718010810171550   1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790   1718041510177230   1718051310179210 1718051310179210 1718051310179210 1718051310179210   1718041510177240 1718041510177240 1718041510177240 1718041510177240 1718041510177240 1718051310179220 1718041510177240 1718041510177240 1718041510177240 1718051310179220   1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830   1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560   1718051310179230 1718051310179230 1718051310179230   1718010810171570 1718010810171570 1718010810171570 1718010810171570 1718010810171570 1718010810171570 1718010810171570 1718010810171570 1718010810171570 1718010810171570 1718051310179240 1718051310179240 1718051310179240 1718051310179240 1718010810171570   1717082810164870 1717082810164870 1717082810164870 1717082810164870 1717101610169170 1717101610169170 1717101610169170 1717101610169170 1717082810164870 1717082810164870   1718071310185370   1718051310179250 1718051310179250 1718051310179250 1718051310179250 1718051310179250   1718051310179260 1718051310179260   1717082810164910 1717082810164910 1717082810164910 1717101610167680 1717101610167680 1717101610167680 1717101610167680 1717101610167680 1717101610167680 1717082810164910 1717101610167680 1717101610167680 1717101610167680 1717101610167680 1717101610167680 1717101610167680 1717101610167680 1717101610167680 1717101610167680   1718061710181860 1718061710181860 1718061710181860   1718041510177250 1718041510177250   1718061710181900 1718061710181900 1718061710181900 1718061710181900 1718061710181900
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : AR, CA, FL, LA, MO, MI, MS, NY, TN, and TX.
  • Descripción del producto
    USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Distributed by US Endovascular, St. Louis, MO.
  • Manufacturer
    Us Endovascular
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall USE PTA 0.014 RX Catheter
Device Recall VariSafe
  • Modelo / Serial
    Model #: 00711819; Lot 1520268
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : OH, OR, WA and Internationally to the country of Italy.
  • Descripción del producto
    Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 || A sterile, single use, flexible sheath device intended to be used for the injection of various types of media through flexible endoscopes
  • Manufacturer
    US Endoscopy Group Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall VariSafe
Device Recall Roth Net Polyp Retrieval
  • Modelo / Serial
    Model # 0071151; Lot #s: 1613898, Exp. Date October 5, 2019; Lot # 1616337, Exp. Date October 7, 2019; Lot # 1616733, Exp. Date October 7, 2019; Lot # 1616734, Exp. Date October 20, 2019 & Lot # 1616735, Exp. Date October 28, 2019.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : AL, CA, CO, IL, KS, MA, MT, NC , NE , NY, OH, PA, TN, TX and WA. Product was also shipped to the following countries: Australia, Belgium, Canada, Czech Republic, Ireland, Kuwait, Norway, Poland & Sweden.
  • Descripción del producto
    Roth Net Polyp Retrieval
  • Manufacturer
    US Endoscopy Group Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Roth Net Polyp Retrieval
Amsco VPRO 1 and Amsco VPRO 1 Plus Low Temperature Sterilization Systems
  • Modelo / Serial
    Model #MLR, V-PRO 1: S/N 033250701 through S/N 031571106; V-PRO 1 Plus: S/N 031800801 through S/N 031581115
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA (nationwide) including the states of: AK, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV & WY, and countries of: Australia, Bangladesh, Belgium, Belarus, Brazil, Canada, Chile, China, Colombia, Costa Rica, Denmark, Ecuador, Egypt, Finland, France, Germany, Hungary, India, Iraq, Ireland, Italy, Japan, Kuwait, Lebanon, Mexico, New Zealand, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, South Korea, Spain, Switzerland, Turkey, Vietnam, United Arab Emirates, and United Kingdom.
  • Descripción del producto
    Amsco¿ V-PRO 1 and Amsco¿ V-PRO 1 Plus Low Temperature Sterilization Systems Model #MLR, Serial # 033250701 - 031581115. || The STERIS Amsco¿ V-PRO and V-PRO 1 Plus Low Temperature Sterilizer are self-contained stand alone devices, using vaporized hydrogen peroxide as the sterilant. The sterilizer is intended for use in the terminal sterilization of cleaned, rinsed, and dried, reusable metal and nonmetal medical devices used in healthcare facilities. The sterilization cycle operates at low pressure and temperatures, and is therefore suitable for processing medical devices sensitive to heat and moisture.
  • Manufacturer
    Steris Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Amsco VPRO 1 and Amsco VPRO 1 Plus Low Temperature Sterilization Systems
SYSTEM 1E Liquid Chemical Sterilant Processing System
  • Modelo / Serial
    Model # P6500, S/N: 400001 through 405005
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the country of Bahrain.
  • Descripción del producto
    SYSTEM 1E Liquid Chemical Sterilant Processing System, Model # P6500, S/N: 400001 through 405005; Mfr. By: STERIS Corporation, Mentor, OH 44060. || Product Usage: The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
  • Manufacturer
    Steris Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de SYSTEM 1E Liquid Chemical Sterilant Processing System
Device Recall Reliance Vision Single Chamber Washer/Disinfector
  • Modelo / Serial
    Model #: 1802983
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including states of: L, AR, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI and WY; and countries of: Australia, Canada, Hong Kong and South Korea.
  • Descripción del producto
    Reliance Vision Single Chamber Washer/Disinfector, Model # 1802983, || The Vision Single Chamber Washer is intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid surgical instruments such as forceps and clamps, theatre shoes and other similar and related articles found in healthcare facilities.
  • Manufacturer
    Steris Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Reliance Vision Single Chamber Washer/Disinfector
Device Recall Verify SixCess Indicator Strips
  • Modelo / Serial
    Model #: PCC005, PCC006, PCC007, PCC008, PCC031, PCC033, PCC034, PCC037 & PCC038,
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Lebanon and Qatar.
  • Descripción del producto
    Verify¿ SixCess Indicator Strips, Model #: PCC005, PCC006, PCC007, PCC008, PCC031, PCC033, PCC034, PCC037 & PCC038, Mfr. By: Albert Browne, LTD, Chancery House 190 Waterside Rd. Hamilton Industrial Park, Leicester, Leicester, LE5QZ, United Kingdom. || Verify¿ SixCess Indicator Strips are used to confirm that the parameters of sterilization have been reached within packs, pouches and wrapped items processed through a steam sterilization process. Each indicator strip is specific to a sterilization temperature and type (i.e. 250¿F 30 minute Gravity Cycle).
  • Manufacturer
    Steris Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Verify SixCess Indicator Strips
Device Recall Verify SixCess Challenge Pack
  • Modelo / Serial
    Model #'s: LCC003, LCC005, LCC014 & LCC310.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Lebanon and Qatar.
  • Descripción del producto
    Verify¿ SixCess Challenge Pack, Model #'s: LCC003, LCC005, LCC014 & LCC310, Mfr. By: Albert Browne, LTD, Chancery House 190 Waterside Rd. Hamilton Industrial Park, Leicester, Leicester, LE5QZ, United Kingdom. || Verify¿ SixCess Challenge Packs are used to confirm that that critical parameters of steam sterilization have been reached within a challenging test pack design. Each challenge pack is also specific to a sterilization temperature and type (i.e. 275¿F 3 minute Prevacuum Cycle).
  • Manufacturer
    Steris Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Verify SixCess Challenge Pack
Device Recall SYSTEM 1E Liquid Chemical Sterilant Processing Systm
  • Modelo / Serial
    MED. Serial Numbers: 400000 through 405499 are subject to correction.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries of: Bahrain, Hong Kong, Japan and South Korea.
  • Descripción del producto
    STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. || The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
  • Manufacturer
    Steris Corporation Hopkins Facility
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall SYSTEM 1E Liquid Chemical Sterilant Processing Systm
Device Recall Infinity sampling device, Cytology Brush
  • Modelo / Serial
    Lot numbers 49680, 50793, 50794, 50795, 52577 & 53023.
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including CA, FL, GA, IA, IL, MA, ME, MN, MO, NC, NH, OH, OK, PA, TN, TX, VA, WA & WV and the countries of Australia, Canada, Columbia, Finland, Germany, India, Israel, Italy, Netherlands, New Zealand & United Kingdom.
  • Descripción del producto
    Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 || The Infinity sampling device is a disposable cytology brush used to retrieve cytological cell samples in the gastrointestinal tract.
  • Manufacturer
    US Endoscopy Group Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Infinity sampling device, Cytology Brush
Device Recall Raptor
  • Modelo / Serial
    Model #00711177; S/N: 52979, 52981, 52982, 53643, 53644, 53891, 53892, 54238
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA (nationwide) including the states of AL, AR, AZ, CA, FL, GA, HI, IA, IL, KY, LA, MD, ME, MI, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, and WI; and to the following countries: Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Caribbean, Chile, Columbia, Croatia, Czech Republic, Denmark, Ecuador, El Salvador, Estonia, Finland, France, Germany, Great Britain, Greece, India, Ireland, Israel, Italy, Jordan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, and United Arab Emirates.
  • Descripción del producto
    Endoscopic retrieval device. || The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal tract or biliary tract.
  • Manufacturer
    US Endoscopy Group Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Raptor
Device Recall Torrent" irrigation tubing
  • Modelo / Serial
    Product code: 00711560; Lot #'s: 79687, 79688, 79689, 79690, 79691, 79692, 79693, 79694, 79695, 79696 80165, 80166, 80709, 80710, 80711, 80712, 80713, 80714, 80715, 80716, 80717, 80718, 80719. 80720, 80721, 80722, 80723, 81245, 81246, 81247, 81248, 81249, 81250, 81251, 81252, 81253, 81254, 81255, 81256, 81257, 81258, 81259, 81982, 81983, 81984, 81985, 81986, 81987, 81988, 81989, 81990, 81991, 82567, 82568, 82569, 82570, 82938, 82939, 82940, 82941, 82942, 82943, 82944, 82945, 82946, 82947, 82948, 82949, 82950, 82951, 82953, 82954, 82955, 82956, 84615, 84616, 84617, 84618, 84619, 84620, 84979, 84981, 85557, 86026, 86028, 86434, 86435 & 86436.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution - including the states of: AK, AL, AZ, CA, CO, CT, DE, FL, GA, ID, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI & WV.
  • Descripción del producto
    Torrent" irrigation tubing. || Product Usage: The Torrent irrigation system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit.
  • Manufacturer
    US Endoscopy Group Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Torrent" irrigation tubing
Device Recall Harmony LA 500
  • Modelo / Serial
    Serial Numbers 0428102135-0428307020
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- United States, Canada, Algeria, Australia, Bahrain, Bangladesh, Brazil, Chile, China, Costa Rica, Ecuador, El Salvador, France, Germany, Guam, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Malaysia, Mexico, New Zealand, Nigeria, Pakistan, Philippines, Poland, Qatar, Russia, Saudi Arabia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, United Arab Emirates, United Arab Emirates, United Kingdom, Italy, Yemen and United Arab Emirates.
  • Descripción del producto
    Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the Harmony LA 500, B129382391. || Designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. Intended to be used in a surgical setting.
  • Manufacturer
    Steris Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Harmony LA 500
Device Recall Harmony LA 700
  • Modelo / Serial
    Serial Numbers 0408504214-0417907007
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- United States, Canada, Algeria, Australia, Bahrain, Bangladesh, Brazil, Chile, China, Costa Rica, Ecuador, El Salvador, France, Germany, Guam, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Malaysia, Mexico, New Zealand, Nigeria, Pakistan, Philippines, Poland, Qatar, Russia, Saudi Arabia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, United Arab Emirates, United Arab Emirates, United Kingdom, Italy, Yemen and United Arab Emirates.
  • Descripción del producto
    Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the Harmony LA 700, B129382393. || Designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. Intended to be used in a surgical setting.
  • Manufacturer
    Steris Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Harmony LA 700
Device Recall Harmony LC 500
  • Modelo / Serial
    Serial Numbers 0436005042-0430207104
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- United States, Canada, Algeria, Australia, Bahrain, Bangladesh, Brazil, Chile, China, Costa Rica, Ecuador, El Salvador, France, Germany, Guam, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Malaysia, Mexico, New Zealand, Nigeria, Pakistan, Philippines, Poland, Qatar, Russia, Saudi Arabia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, United Arab Emirates, United Arab Emirates, United Kingdom, Italy, Yemen and United Arab Emirates.
  • Descripción del producto
    Harmony Lux Classic, Surgical Lighting System, also known as the Harmony LC 500, B129388085 and B12988086. || Designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. Intended to be used in a surgical setting.
  • Manufacturer
    Steris Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Harmony LC 500
Device Recall Reliance EPS Endoscope Processing System
  • Modelo / Serial
    Model #'s: MB30001, MB30002, MB30003, MB000077, MB000078, MB000079, MB000080 & MB000081
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA, including states of AK, AL, AZ, CA, CO, DE, FL, ID, IL, KS, KY, MD, MI, MN, MO, NC, NV, NY, OH, PA, SC, VA, WA, WI, and WY, and countries of Algeria, Australia, Belarus, Canada, France, Germany, Greece, India, Italy, Japan, Kuwait, Lebanon, New Zealand, Russian Federation, Saudia Arabia, Spain, Turkey, United Arab Emirates and United Kingdom.
  • Descripción del producto
    Steris Reliance EPS Endoscope Processing System , manufactured by Corporation STERIS Canada, Quebec, Canada. || Washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-resistant, semi-critical endoscope devices.
  • Manufacturer
    Steris Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Reliance EPS Endoscope Processing System
Device Recall Harmony LA/LED Arm Adapter
  • Modelo / Serial
    Model Number: LB61
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including CO, IL, IN, MO, NC, NV, NY and OH and the countrries of Canada, China, and Australia.
  • Descripción del producto
    Harmony LA/LED Monitor Arm Adapter. Model Number: LB61 || The Harmony LA/LED Monitor Arm Adapter is an accessory to the Harmony LA and LED Surgical Lighting System and is attached to the end of the monitor suspension arm to allow Customers to attach other medical devices, such as non-STERIS monitors, camera or other compatible items in place of the STERIS monitor. The Harmony Surgical Lighting and Media System is a family of variable pattern, variable intensity surgical lights designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. The device is intended to be used by surgeons and other medical care practitioners in a surgical setting
  • Manufacturer
    Steris Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Harmony LA/LED Arm Adapter
Device Recall SYSTEM 1E liquid chemical sterilant processing system
  • Modelo / Serial
    All codes manufactured from 5/5/2010 through 3/8/2011, are subject to recall/correction.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: USA including states of :CA, DE, FL, GA, IA, ID, IL, KS, MA, MO, MT, NE, NJ, NM, NY, OH, OR, SD, TX, VA, WA, WI, and WV.
  • Descripción del producto
    STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System || The SYSTEM 1 E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned impressible, reusable, critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories. Devices processed in a SYSTEM IE have been chemically sterilized using S40 Sterilant Concentrate, a peracetic acid liquid chemical sterilant and rinsed with extensively treated, potable water.
  • Manufacturer
    Steris Corporation Hopkins Facility
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall SYSTEM 1E liquid chemical sterilant processing system
Device Recall Talon Grasping Device
  • Modelo / Serial
    Model #00711175; Lot #'s: 1407418, 1407419, 1408069, 1408070, 1408739, 1408740, 1408741, 1408742, 1410178, 1410179, 1410478, 1410480, 1410990, 1411518, 1423937, and 1423938.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Product was shipped to the following states: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI & WV. Product was also sent to the following countries: ARGENTINA, AUSTRALIA, BELGIUM, CANADA, ESTONIA, FRANCE, MEXICO, NEW ZEALAND, SAUDI ARABIA & SWEDEN.
  • Descripción del producto
    Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies, tissue specimens, stones or calculi in endoscopic procedures of the gastrointestinal tract.
  • Manufacturer
    US Endoscopy Group Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Talon Grasping Device
UroSeal Adjustable Endoscopic Valve
  • Modelo / Serial
    Lot 1417696
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed to the states of FL, MO, OH and WI.
  • Descripción del producto
    UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 || The primary packaging is a Tyvek pouch. The secondary package is a corrugate box. 5 units per box. || Used to cover the opening to the biopsy/suction channel of an endoscope.
  • Manufacturer
    US Endoscopy Group Inc
  • 1 Event
    • Retiro De Equipo (Recall) de UroSeal Adjustable Endoscopic Valve
Device Recall Velocity Biopsy Valve
  • Modelo / Serial
    M/N: 00711140; Lot #'s: 1401267, 1404503, 1408953, 1413362, 1417521, 1420739, 1422288, 1422747, 1424014, and 1500443.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of: CA, CO, IA, MA, OH, TX & WV and the countries of: Brazil, Costa Rica, Croatia, Czech Republic, Egypt, France, Germany, India, Indonesia, Italy, Latvia, Lithuania, Philippines, Poland, Romania, Russian Federation, Slovenia & South Africa.
  • Descripción del producto
    Velocity" Biopsy Valve, 25 units per box, || Product Usage: || The disposable Velocity biopsy valve is used to cover the opening of the biopsy inlet port of a flexible gastrointestinal endoscope. The Velocity biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation, and minimizes leakage of biomaterial from the accessory port throughout the gastrointestinal endoscopic procedure. The Velocity biopsy valve provides a connection for irrigation through the Velocity irrigation pump.
  • Manufacturer
    US Endoscopy Group Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Velocity Biopsy Valve
Device Recall Histolock Resection Device
  • Modelo / Serial
    M/N: 00711117; Lot #: 1505956
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to states of: AL, AR, CA, IL, IN, MS, OH, OK & TN.
  • Descripción del producto
    Histolock Resection Device, US Endoscopy. || An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.
  • Manufacturer
    US Endoscopy Group Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Histolock Resection Device
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