Events

Retiro De Equipo (Recall) de UA767PBTCi for small cuff; Blood Pressure Monitor Cardiology

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 A & D Enginering 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
    75177
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0063-2017
  • Fecha de inicio del evento
    2016-09-12
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149547
  • 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, measurement, blood-pressure, non-invasive - Product Code DXN
  • Causa
    A&d; may have shipped blood pressure monitors that were not labeled for use with small cuff.
  • Acción
    Notification letters were sent on September 12, 2016 to all affected customers. Letters identify the product and reason for the recall. Letters include a serial number list that is customer specific and ask that inventory be reviewed and that other organizations that may be impacted by this issue be notified.

Device

UA767PBTCi for small cuff; Blood Pressure Monitor Cardiology
  • Modelo / Serial
    Serial numbers: 5150100209  5150100207  5150100204  5150100203  5150100210  5150301449  5150301448  5150301444  5150301445  5150301446  5150301443  5150301450  5150301441  5150301442  5150301447  5150402687  5150402720  5150402711  5150402729  5150402714  5150402830  5150402810  5150402826  5150402839  5150402730  5150402835  5150402716  5150402762  5150402769  5150402768  5150402834  5150402726  5150402832  5150402809  5150402829  5150402764  5150402823  5150402760  5150402806  5150402787  5150402756  5150402784  5150402761  5150402783  5150402801  5150402821  5150402802  5150402805  5150402833  5150402824  5150402838  5150402649  5150402827  5150402650  5150402804  5150402757  5150402685  5150402763  5150402770  5150402790  5150402645  5150402755  5150402715  5150402782  5150402789  5150402753  5150402807  5150402644  5150402803  5150402688  5150402767  5150402786  5150402686  5150402721  5150402713  5150402682  5150402728  5150402717  5150402723  5150402689  5150402712  5150402752  5150402727  5150402725  5150402648  5150402684  5150402690  5150402642  5150402647  5150402683  5150402719  5150402759  5150402766  5150402751  5150402681  5150402754  5150402765  5150402722  5150402724  5150402758  5150402643  5150402718  5150402641  5150402788  5150402837  5150402828  5150402646  5150402840  5150402836  5150402808  5150402781  5150402822  5150402785  5150402825  5150402831  5150200109  5150200108  5150200469  5150200468  5150200102  5150200242  5150200103  5150200529  5150200522  5150200526  5150200525  5150200467  5150200523  5150200521  5150200528  5150200527  5150200465  5150200341  5150200463  5150200106  5150200342  5150200105  5150200343  5150200345  5150200347  5150200349  5150200241  5150200247  5150200243  5150200244  5150200246  5150200248  5150200249  5150200250  5150200245  5150200348  5150200346  5150200350  5150200344  5150200107  5150200524  5150200464  5150200470  5150200461  5150200462  5150200466  5150200530  5150200104  5150200110  5150200101  5150100992  5150100997  5150100994  5150100993  5150100999  5150101126  5150101122  5150100991  5150100995  5150101123  5150100998  5150101128  5150101125  5150101127  5150100996  5150101000  5150101124  5150100630  5150100870  5150100869  5150100861  5150100864  5150100868  5150100866  5150100867  5150100863  5150100862  5150100865  5150101129  5150101121  5140601121  5140601127  5140601123  5140601126  5140601124  5140601122  5140601129  5140601125  5140601128  5140601199  5140601200  5140601194  5140601196  5140601195  5140601130  5140601191  5140601193  5140601198  5140601192  5140601197  5140800577  5140800575  5140800580  5140800573  5140800579  5150402489  5150402488  5150402396  5150402467  5150402521  5150402490  5150402567  5150402466  5150402463  5150402528  5150402465  5150402525  5150402529  5150402564  5150402313  5150402315  5150402316  5150402319  5150402317  5150402311  5150402568  5150402392  5150402399  5150402486  5150402484  5150402487  5150402485  5150402523  5150402526  5150402483  5150402469  5150402462  5150402481  5150402464  5150402470  5150402461  5150402468  5150402530  5150402522  5150402524  5150402400  5150402318  5150402391  5150402393  5150402562  5150402482  5150402312  5150402394  5150402570  5150402397  5150402566  5150402320  5150402398  5150402314  5150402569  5150402412  5150402416  5150402414  5150402417  5150402413  5150402418  5150402411  5150402420  5150402527  5150402563  5150402357  5150402135  5150402565  5150402561  5150402415  5150402419  5150402395  5150402138  5150402139  5150402132  5150402134  5150402131  5150402351  5150402358  5150402355  5150402354  5.06001E+12  5150402129  5150402126  5150402127  5150402130  5150402125  5150402356  5150402352  5150402137  5150402136  5150402133  5150402360  5150402140  5150402353  5150301760  5150301752  5150301716  5150301720  5150301751  5140800617  5140800482  5140800613  5140800489  5140800619  5140800488  5140800614  5140800483  5140800615  5140800490  5140800620  5140800612  5140800616  5140800618  5140800611  5140800486  5140800481  5140800484  5140800487  5140800485  5140800576  5140800578  5140800571  5140800574  5140800572  5150301725  5150301733  5150301724  5150200069  5150200068  5150200066  5150200063  5150200070  5150200061  5150200065  5150200064  5150200067  5150200062  5150702417  5150702411  5150702416  5150702418  5150702413  5150701011  5150702153  5150702159  5150702155  5150702156  5150702322  5150702157  5150702327  5150702154  5150702329  5150702326  5150702151  5150702152  5150702160  5150702158.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    to distributors in NY, MA, VA. TX,
  • Descripción del producto
    Blood Pressure Monitor UA-767PBT-Ci for small cuff. Designed to be used by end users who are eighteen (18) years and older at home to monitor their blood pressure (systolic and diastolic) and pulse rate.
  • Manufacturer
    A & D Enginering Inc

Manufacturer

A & D Enginering Inc
  • Dirección del fabricante
    A & D Enginering Inc, 1756 Automation Pkwy, San Jose CA 95131-1873
  • Empresa matriz del fabricante (2017)
    A&D Co., Ltd.
  • Source
    USFDA