Events

Retiro De Equipo (Recall) de PowerLED 700 Surgical Light System

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 Maquet Medical Systems USA.

¿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
    68142
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1730-2014
  • Fecha de inicio del evento
    2014-04-16
  • Fecha de publicación del evento
    2014-06-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-04-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126999
  • 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
    Maquet has identified an issue with the maquet powerled 700 (certain serial numbers). one or several plastic fixation tabs can break, which can cause the ambient light module to partially detach.
  • Acción
    Maquet issued "Urgent-Medical Device Field Correction" notices, dated April 16, 2014 to affected customers via Federal Express. The notice identified the product, related issue and the action needed to be taken by the customer. The corrective action will include inspection of the fixation tabs of the Ambient Light Module adn replacement of the Ambient Light Module if tabs are found to be defective. The correction will be performed by an authorized MAQUET Service Technician. MAQUET Service Team representatives will schedule on-site service with customers. If customers have any questions or require additional information, the notice instructs them to contact their local MAQUET representative, or MAQUET Customer Service at 1-888-627-8383 (option 3), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST.

Device

PowerLED 700 Surgical Light System
  • Modelo / Serial
    Part number (begins with ALM) and associated serial numbers:  ALM568300999 13, 14, 16, 19, 20, 21, 22, 23, 24, 25, 29, 30, 31, 32, 34, 35, 36, 41, 50  ALM568301999 13, 14, 16, 17, 20, 23, 24, 25, 26, 52, 54, 55, 56, 57, 60, 63, 64, 65, 66, 70, 71, 72, 74  ALM568302999 11, 43, 44, 46, 49, 50, 51, 54, 57, 58, 59, 6, 61, 63, 64, 66, 67, 71, 72, 74, 77, 78, 80, 81  ALM568303999 8, 9, 32, 52, 53, 58, 60, 61, 62, 65, 66, 69, 70, 71, 73, 74, 75, 77, 78, 79, 80, 81, 82, 85, 86, 87, 89, 91, 92, 94, 95, 96, 97, 99, 100, 105, 106, 108, 111, 118, 120, 121, 122, 159  ALM568320901 12012, 40015, 40017, 40018, 40019, 40020, 40021, 50010, 50011, 50012, 50013, 50014, 50015, 50016, 50017, 50018, 50019, 50020, 50021, 50022, 50023, 50024, 50025, 50026, 50027, 50028, 50030, 50031, 50032, 50033, 50034, 50035, 50037, 50038, 50039, 50040, 50041, 50042, 50043, 50047, 50048, 50050, 50051, 50052, 50053, 50054, 50055, 50056, 50058, 50059, 50060, 50061, 50064, 50066, 50067, 50068, 50069, 50070, 50071, 50072, 70033, 70034, 70035   ALM568320905 40003, 40004, 40005, 40006, 40007, 40008, 40009, 40010, 40011, 40012, 40013, 40014, 40015, 40016, 50003, 50004, 50005, 50006, 50008, 50009, 50010, 50011, 50012, 50013, 50014, 50015, 50016, 50017, 50018, 50019, 50020, 50021, 60003, 60004, 70001, 70002, 70003, 70004, 70005, 70006, 70007, 70009, 70010, 70011, 70012, 70013, 70014, 70015, 70016, 70017, 70018, 70019, 70020, 70021, 70022, 70024, 70025, 70027, 70028, 70029, 70030, 70031, 70032, 70033, 70034, 70035, 70036, 70037, 70038, 70039, 70040, 70041, 70042, 70043, 70044, 70045, 70046, 70047, 70048, 70049, 70050, 70051, 70052, 70053, 70054, 70055, 70056, 70057, 70058, 70059, 70060, 70061, 70063, 70064, 70066, 70068, 70069  ALM568370900 20017, 20018, 20019, 20020, 20021, 20022, 20023, 20024, 20025, 20026, 20027, 20028, 20029, 20030, 20039, 20040, 20041, 20042, 20043, 20044, 20045, 20046, 20047, 20048, 20049, 20050, 20051, 20052, 20053, 20054, 30038, 30039, 30053, 30054, 40006, 40010, 40012, 40013, 40014, 40015, 40016, 40018, 40019, 40020, 40027, 40028, 40029, 40030, 40031, 40032, 40033, 40034, 50000, 50001, 50004, 50006, 60007, 60008, 60009, 60010, 60012, 60031, 60041, 60042, 60043, 60044, 60046, 60047, 60048   ALM568370901 20024, 20025, 20026, 20027, 20028, 20029, 20030, 20031, 20032, 20033, 20034, 20038, 20039, 20040, 20041, 20042, 20045, 20053, 20054, 20055, 20056, 20057, 20058, 20059, 20060, 20061, 20062, 20064, 20065, 20066, 20067, 20068, 20069, 20070, 32042, 40028, 40033, 40034, 40035, 40036, 40037, 40038, 40045, 50002, 50006, 50008, 50009, 50024, 50035, 50036, 50037, 50039, 50040, 50041, 50042, 50043, 50044, 50045, 50046, 50047, 50048, 60030   ALM568370902 20011, 20015, 20016, 20017, 20018, 20019, 20020, 20021, 20022, 20023, 20024, 20025, 20026, 20027, 20028, 20029, 20030, 20031, 20032, 20033, 20034, 20035, 20036, 20037, 20038, 20039, 20040, 20041, 20042, 20048, 20049, 20050, 20051, 20057, 20058, 20059, 20060, 20061, 20062, 20063, 20064, 20067, 20068, 20069, 20070, 20071, 20072, 20073, 20074, 20075, 20076, 20077, 20078, 20079, 20080, 20083, 20086, 20087, 20089, 20090, 20091, 20094, 20095, 20096, 20098, 20104, 20105, 20106, 20107, 20108, 20109, 20110, 20111, 20112, 20113, 20114, 20115, 20116, 20117, 20118, 20119, 20120, 20121, 20122, 20123, 20124, 20125, 20127, 20132, 20133, 20135, 20136, 20137, 20139, 20140, 20141, 20144, 20151, 20152, 30000, 30051, 30053, 30054, 30062, 30063, 30065, 30066, 30067, 30068, 30078, 30081, 30090, 30091, 30092, 30099, 30107, 30127, 30128, 30130, 30131, 30134, 32164, 40000, 40006, 40007, 40009, 40011, 40012, 40013, 40014, 40015, 40017, 40018, 40019, 40020, 40021, 40023, 40039, 40040, 40041, 40042, 40043, 40044, 40045, 40046, 40047, 40048, 40050, 40051, 40052, 40053, 40054, 40055, 40056, 40057, 40058, 40060, 40064, 40065, 40067, 40078, 40081, 40082, 40083, 40084, 60030, 60031, 60036   ALM568370903 20022, 20023, 20024, 20025, 20026, 20027, 20028, 20029, 20030, 20032, 20033, 20034, 20035, 20036, 20037, 20038, 20039, 20041, 20043, 20044, 20045, 20046, 20047, 20048, 20049, 20050, 20051, 20052, 20053, 20055, 20056, 20057, 20058, 20059, 20066, 20067, 20072, 20073, 20074, 20075, 20076, 20077, 20079, 20080, 20081, 20082, 20084, 20087, 20088, 20089, 20090, 20091, 20092, 20093, 20097, 20098, 20099, 30072, 40025, 50000, 50001, 50002, 50003, 50004, 50006, 50028, 50051, 50052, 50054, 50055, 50057, 50058, 50059, 50060, 60024, 60025, 60026, 60028  ALM568370904 20011, 20013, 20014, 20015, 20016, 20017, 20018, 20019, 20020, 20023, 20024, 20025, 20026, 20027, 20032, 20033, 20034, 20035, 20036, 20037, 20038, 30000, 30001, 30002, 30003, 30004, 30012, 30013, 30014, 30015, 30018, 30019, 30020, 30025, 30026, 30027, 30028, 30029, 30030, 30031, 30032, 30033, 30034, 30035, 30036, 30037, 30038, 30039, 30040, 30041, 30042, 30043, 40011, 40012, 40013, 40014, 40015, 40016, 40017, 40022, 40023, 40024, 40031, 40032, 40033, 40034, 40035, 40036, 50004, 50010, 50011, 50012, 50013, 50014, 50015, 50016, 50017, 50019  ALM568370905 20010, 20016, 20017, 20018, 20019, 20022, 20023, 30027, 40012, 40022, 40023, 40024, 40025, 40027, 40028, 40029, 40031, 40032, 40033, 40037, 40040, 40041, 40047, 40049, 40050, 50005, 50006, 50012, 50015, 50018, 50021, 60007, 60023, 60027, 60030, 60032, 60033
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution.
  • Descripción del producto
    Maquet PowerLED 700. || Product Usage; To provide illumination to the surgical area or the patient.
  • Manufacturer
    Maquet Medical Systems USA

Manufacturer

Maquet Medical Systems USA
  • Dirección del fabricante
    Maquet Medical Systems USA, 45 Barbour Pond Dr, Wayne NJ 07470-2094
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    USFDA