Events

Retiro De Equipo (Recall) de Device Recall Mobile wDR motorized portable diagnostic Xray systems.

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 Sedecal S.A..

¿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
    73428
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1084-2016
  • Fecha de inicio del evento
    2016-01-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-02-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144185
  • 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
    System, x-ray, mobile - Product Code IZL
  • Causa
    This is related to previous 806 notifications about uncommanded movements of a motorized mobile x-ray system. reason for recall: along with the previously noted encoder and gauges problems and corresponding fixes, we have observed that static electricity can also elicit the unwanted behavior.
  • Acción
    Philips Medical Systems sent an URGENT - Field Safety Notice letter dated August 6, 2014 was sent to all consignees of record informing them of a potential safety issue on the SEDECAL mobile units manufactured from May 2013 on. The firm requests the direct acounts with affected units should take the following steps: 1) The unit is equipped with a safety switch in the drive handle. If the drive handle is released the unit will stop; 2) Do not try to correct unintended movement using the controls on the drive handle; 3) Instead, stop the system immediately by releasing the drive handle entirely; 4) Alternatively, the emergency button can be pressed; 5) Take special care when the system crosses metal strips or plates on the floor or enters an elevator, as these are situations where electrostatic discharge is likely to occur; and, 6) Should the customer feel uncertain regarding this action, he/she can contact Philips Healthcare. Philips is preparing a Field Action Kit to replace the existing arrestor strap by a new arrestor with higher resistivity. This will reduce the electromagnetic pulse to a level, which is safe to not disturb the electronics. A Philips Service Engineer will contact the direct accounts to distribute Field Action Kit. The firm states that should direct accounts need to communicate with Philips in regards to this recall that they reference FC0-71200138. If they need any further information or support concerning this issue, please contact their local Philips representative.

Device

Device Recall Mobile wDR motorized portable diagnostic Xray systems.
  • Modelo / Serial
    Serial Numbers: 485886/SN11000007, 485062/SN11000009, 488169/SN11000011, 485061/SN11000012, 485059/SN11000013, 485060/SN11000015, 489089/SN11000016, 489616/SN11000033, 490027/SN11000034, 489694/SN11000035, 489695/SN11000036, 489696/SN11000037, 490221/SN11000039, 489088/SN11000040, 493566/SN11000047, 493565/SN11000048, 494867/SN11000051, 494941/SN11000052, 492417/SN11000053, 494456/SN11000055, 494865/SN11000056, 494864/SN11000060, 495286/SN11000061, 494866/SN11000062, 494464/SN11000065, 497570/SN11000066, 488171/SN11000068, 494060/SN11000070, 494061/SN11000071, 494062/SN11000072, 494063/SN11000073, 494064/SN11000074, 494065/SN11000075, 497715/SN11000080, 496446/SN11000082, 496387/SN12000003, 495938/SN12000007, 495939/SN12000008, 493364/SN12000022, 493462/SN12000023, 501028/SN12000026, 500739/SN12000027, 500740/SN12000028, 502424/SN12000034, 503143/SN12000036, 503142/SN12000037, 503141/SN12000038, 503144/SN12000039, 503541/SN12000040, 500466/SN12000045, 502721/SN12000047, 505077/SN12000048, 506626/SN12000051, 507607/SN12000054, 507906/SN12000055, 508342/SN12000057, 500468/SN12000058, 496401/SN12000059, 500467/SN12000060, 508838/SN12000061, 508532/SN12000062, 504450/SN12000064, 509718/SN12000068, 510607/SN12000072, 512160/SN12000077, 513477/SN12000080, 513478/SN12000081, 512892/SN12000082, 513848/SN12000084, 512887/SN12000085, 512888/SN12000086, 512890/SN12000087, 508699/SN12000088, 514462/SN12000089, 514461/SN12000090, 514104/SN12000091, 514103/SN12000092, 509062/SN12000107, 508783/SN12000108, 516891/SN12000110, 516896/SN12000111, 497572/SN12000112, 518135/SN12000118, 518342/SN12000119, 518343/SN12000120, 518344/SN12000121, 518345/SN12000122, 518346/SN12000123, 502025/SN12000124, 502026/SN12000125, 12000166, 519326/SN13000005, 519388/SN13000006, 519511/SN13000010, 519506/SN13000011, 519387/SN13000012, 519763/SN13000013, 519434/SN13000014, 520251/SN13000016, 520253/SN13000017, 519762/SN13000018, 520254/SN13000019, 520255/SN13000020, 520256/SN13000021, 520413/SN13000023, 520414/SN13000025, 520415/SN13000026, 520252/SN13000027, 520422/SN13000028, 520418/SN13000030, 520416/SN13000031, 520417/SN13000033, 522633/SN13000035, 522944/SN13000037, 523279/SN13000042, 523349/SN13000043, 13000046, 13000047, 13000048, 13000049, 13000053, 13000054, 13000055, 13000056, 13000057, 13000058, SN13000059, 13000060, SN13000061, SN13000062, SN13000063, 13000067, SN13000069, 13000070, 13000071, SN13000072, SN13000073, SN13000074, 13000075, 13000076, 13000077, 13000078, 13000079, SN13000080, SN13000082, SN13000083, SN13000084, 13000085, SN13000087, SN13000089, SN13000090, SN13000091, 13000092, 13000093, 13000094, SN13000099, SN13000100, SN13000101, SN13000102, SN13000103, SN13000104, SN13000106, SN13000107, 13000109, SN13000112, SN13000113, 519598/SN13000118, 519599/SN13000119, 519600/SN13000120, SN13000125, 13000127, 13000139, 13000140, 13000141, 13000143, 13000144, 13000145, SN13000146, SN13000147, SN13000148, SN13000149, SN13000153, SN13000154, SN13000157, SN7369686, SN13000159, SN13000160, SN13000163, SN13000164, SN13000165, 13000167, 13000168, 13000169, SN13000170, SN13000174, SN13000176, SN13000177, SN13000179, SN13000180, SN13000181, SN13000182, SN13000183, SN13000185, 13000196, 13000199, 13000200, 13000201, 13000202, 13000203, 13000204, 13000205, SN13000206, 14000004, 14000005, 14000006, 14000008, 14000009, 14000010, 14000011, 14000013, 14000014, 14000015, 14000016, 14000017, 14000019, 14000022, 14000024, 14000026, 14000028, 14000029, 14000031, 14000032, 14000033, 14000034, 14000037, 14000038, 14000041, 14000043, 14000046, 14000047, 14000048, 14000049, 14000050, 14000051, 14000052, SN14000061, 14000069, SN14000072, 14000075, 14000077, 14000078, 14000079, 14000080, 14000081, 14000082, 14000084, 14000086, 14000087, 14000088, 14000089, SN14000096, SN14000097, SN14000098, SN14000099, SN14000100, 14000092, 14000083, 14000085, 14000103, 14000106, 14000083, 14000109, 14000112, 14000116, 14000119, 14000118, 14000120, 14000121, 14000122, 14000124, SN14000128, 14000127, 14000126, SN14000130, 14000134, 14000135, 14000138, 14000139, SN15000002, 14100044, 14100045, 14100053, 14100054, 14100085, 14100086, 14100087, 14100088, 14100090, 14100094, 14100095, 14100097, 14100101, 14100104, 14100105, 14100109, 14100111, 14100117, 14100126, 14100127, 14100128, SN14100046, 15100019, 15100023, SN14100047, SN14100055, SN14100071, SN14100072, SN14100073, SN14100074, SN14100075, 15100028, 15100034, 15100035, 15100036, 15100039, 15100040, 15100041, 15100042, 15100047, 15100048, 15100050, 15100071, 15100084, 15100087, 15100088, 15100089, 15100091, 15100092, 15100093, 15100094, 15100095, 15100097, 15100098, 15100101, 15100103, 15100104, SN15100020, SN15100009, SN15100016, SN15100010, SN15100011, SN15100013 and SN15100018.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI.
  • Descripción del producto
    Mobile wDR motorized portable diagnostic X-ray systems. || Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.
  • Manufacturer
    Sedecal S.A.

Manufacturer

Sedecal S.A.