Events

Retiro De Equipo (Recall) de Device Recall Trumpf

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Trumpf Medical Systems, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    71718
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2354-2015
  • Fecha de inicio del evento
    2015-07-27
  • Fecha de publicación del evento
    2015-08-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-05-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138820
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Light, surgical, ceiling mounted - Product Code FSY
  • Causa
    Complaints received of the front joint of the spring arm ac 2000 could break at the interface to the monitor.
  • Acción
    Consignees were notified by letter on/about 7/27/2015.

Device

Device Recall Trumpf
  • Modelo / Serial
    The following Material numbers may appear on any of the attached recalled/corrected units: Material #0376288, Description: Federarm 3kg, 3 polig (Swing); 0376289, Federarm 12-18kg, 5-polig Kamera eco; 0376290, Federarm TFT Stop AC 2000, 9-15kg; 0376291, Federarm TFT Stop AC 3000, 12-18kg; 0376292, Federarm TFT Stop Space bis 30kg; 0376293, Federarm 3-polig NRH; 0376294, Federarm 5-polig NRH; 0376295, Federarm 3-polig NRH gerader Abgang; 0376296, Federarm 5-polig NRH gerader Abgang; 0379528, FA AC3000, Stop 7-11KG; 0385719, FA AC 2000 NRH mobil 3p, 12-18kg NG; 1387323, Federarmsicherungssegment AC3000; 1387324, Federarmsicherungssegment AC2000; 1388338, Federarm 12-18 kg 3 polig, HEL2; 1388339, Federarm 12-18 kg 5 polig HEL2; 1388340, Federarm 12-18 kg 9 polig (HELION); 1408906, FA AC2 Stop max 11kg; 1471010, FA AC2000 3p, 12-18kg; 1471011, FA AC2000 Stop 12-18kg; 1471012, FA AC2000 NRH 3p, 12-18kg; 1471013, FA AC2000, 7p, 12-18kg; 1471014, FA AC2000 NRH 7p, 12-18kg; 1471015, FA AC3000 3p, 23-30kg; 1471016, FA AC2000 Stop 6-11kg; 1471017, FA AC2000 TruVidia 7p, 3,5-7kg; 1471018, FA AC2000 Stop 3,5-7kg; 1471351, FA AC3000 NRH 3p, 23-30kg; 1502084, FA AC2 NRH f¿r HEL2, 3POL.; 1504731, Federarm 9-POLIG NRH HEL2; 1507085, (R)FEDERARM AC2000; 1645860, FA AC 2000 NRH mobil 7p, 12-18kg NG; 1645861, FA AC 2000 NRH 7p, 12-18kg NG; 1649687, FA AC 2000 SlimLine STOP, 12-18kg; 1649872, FA AC 2000 SlimLine 3p, 12-18kg; 1649997, Deckenrohr 2f Slimline 1000; 1774143, Ausleger AC2000, 750mm, 3p; 1982310, FA AC2000 MAVIG Protegra2 6-11kg; 1982311, FA AC2000 MAVIG Protegra2 12-18kg; 1982312, FA AC2000 3p, 13,5-21kg; 1982313, FA AC2000 NRH 3p, 13,5-21kg; 4024211, Federarm AC2000; 4024212, FA AC2 Stop; 4024213, FA AC3; 4024214, FA AC3000 Stop, 12-18kg; 4024215, FA AC5000 Stop; 4024651, FA AC3000, 7p; 4024652, FA AC2 3K; 024848, Federarm AC3000 NRH; 4025574, FA AC3000 Stop 23-30 kg; 4025575, FA AC5000 Stop max 15 kg; 4025576, FA AC2 K TruVidia; 8800900, Federarm HELION L+ 12,5 kg 5-polig; 8800901, Federarm HELION M+ 12,5 kg 3-polig; 8800905, Federarm HEL L/L+, 11,4 kg 3-polig; 8800906, Federarm HELION M NRH; 8800907, Federarm FA 77 V 11,4 kg 3 polig; 8800908, Federarm FA 77 V 6,8 kg 3 polig; 8800909, Federarm f¿r L-Leuchte So-Version; 8800910, Federarm f¿r M-Leuchte So-Version; 8800911, Federarm FA 77 V 13 kg 3 polig; 8800915, Federarm FA 77 N 11,4 kg5 polig; 8800916, Federarm FA 77 N 6,8 kg 5 polig; 8800919, Federarm FA 77 N 13 kg 5 polig; 8800920, Federarm FA 77 N 8,9 kg 5 polig; 8800925, Federarm FA 77 N 11,4 kg 7 polig; 8800926, Federarm Helion M NRH 7-polig; 8800929, Federarm FA 77 N 13 kg 7 polig; 8800930, Federarm FA 77 N 8,9 kg 7 polig; 8801000, Federarm HELION M+ 8.3 kg 5-polig; 8801001, Federarm HELION M+ 8,3 kg 3-polig; 8801007, Federarm AC 2000, 9-15 kg O. Elektrik; 8801008, Federarm AC 2000, 7-12 kg 5 polig; 8801009, Federarm AC 2000, 12-18 kg 5 polig; 8801010, Federarm Acrobat 2000 12-18 kg; 8801011, Federarm; 8801012, Federarm AC 2000 7-15 kg 3 polig mit; 8801013, Federarm AC 2000, 9-15 kg 7 polig; 8801014, Federarm f¿r Helion M; 8801015, Federarm AC 2000, 1-3,5 kg 7 polig; 8801016, Federarm AC2000 9-15 kg 5-polig; 8801017, Federarm HELION S Mobile; 8801018, Federarm AC 2000, 12-18 kg 3 polig; 8801019, Federarm AC 2000, 1-3,5 kg 3 polig; 8801020, Federarm AC 2000, 12-18 kg 7 polig; 8801021, Federarm AC 2000, 1-3,5KG, Adapt. Anschl; 8801033, Federarm Deckenanschlu¿ HELS; 8801050, Federarm AC 3000, 12-18 kg ohne Elektr.; 8801051, Federarm SPACE 20-40 kg ohne Elektrik; 8801101, Federarm SWING 2-3 kg 3 POL. 120 Volt; 8801102, Federarm SWING 2-3 kg 3 POL. 230 Volt; 8801103, Federarm f¿r HELION S; 8801104, Federarm SWING 2-3 kg 3 polig; 8807200, Federarm 6.5kg f¿r HELION M+ Mobile; 8894025, Federarm WA 77, 8,3 kg 3 polig; 1425487, FA AC2 STOP 3,5KG - MAX 7KG; 1768718; FA AC 77, NRH 3P; 0385246, FA AC2000 NRH 3P, 12-18KG; 4024790, FA AC3000 NRH 7P; 1419354, FA AC3000 STOP (17 -26KG); 0384021, FA AC2000 NRH MOBIL 3P 12-18KG; 0385247, FA AC2000 NRH MOBIL 7P, 12-18KG; 1695239, ACHSE 1F WL 800, 3P + FA SWING; 1695224, ACHSE 1F ZA 800, 3P + FA SWING; 1886331, BEFESTIGUNGSSET FA AC 77/2000/SWING; and Material #1695225, Description: STATIV MOBIL TL1000, 3P + FA SWING.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US (nationwide) including Puerto Rico, and the countries of Angola, Antilles, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Belgium, Bulgaria, Bahrain, Brasilia, Belarus, Canada, Switzerland, Chile, China, Columbia, Cyprus, Czech Republic, Germany, Denmark, Algerian, Ecuador, Estonia, Egypt, Spain, Finland, France, Gabon, United Kingdom, Georgian Republic, Greece, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Iraq, Iran, Iceland, Italy, Jordan, Japan, Kenya, South Korea, Kuwait, Kazakhstan, Lebanon, Liechtenstein, Lithuania, Luxembourg, Latvia, Libya, Morocco, Macedonia, Myanmar/Burma, Malta, Mauritius, Mexico, Malaysia, Netherlands, Norway, New Zealand, Peru, Philippines, Pakistan, Poland, Palestine, Portugal, Qatar, Romania, Russia, Saudi Arabia, Sudan, Sweden, Singapore, Slovenia, Slovakia, San Marino, Syria, Thailand, Turkmenistan, Tunisia, Turkey, Taiwan, Ukraine, United Arabian Emirates, Uruguay, Venezuela, British Virgin Islands, Vietnam, Kosovo, Serbia and South Africa.*
  • Descripción del producto
    Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia HD, User Manual #1513140. || The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
  • Manufacturer
    Trumpf Medical Systems, Inc.

Manufacturer

Trumpf Medical Systems, Inc.
  • Dirección del fabricante
    Trumpf Medical Systems, Inc., 1046 Legrand Blvd, Charleston SC 29492-7672
  • Empresa matriz del fabricante (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA