Events

Retiro De Equipo (Recall) de Inpeco SA FlexLab, Accelerator a3600 and Aptio Automation

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 Inpeco 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
    75513
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0587-2017
  • Fecha de inicio del evento
    2016-10-04
  • Estado del evento
    Completed
  • 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=150626
  • 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
    Electrode, ion specific, potassium - Product Code CEM
  • Causa
    Inpeco received several notifications from the field about burnt schuko sockets. the customers reported that some smoke was seen coming from the damaged sockets.
  • Acción
    Inpeco sent an Urgent Field Safety Notice dated October 2016 for the Aptio Automation, the Accelerator a3600 and the FlexLab Shucko power cord cables to all affected US and foreign customers. The Urgent Field Safety Notice described the reason for the recalls and actions that should be taken. The firm is requesting all customers to complete and return the Field Correction Effectiveness Check form attached to the Urgent Field Safety Notice letter within 7 days. The Urgent Field Safety Notice letter should be forwarded to affected departments or consignees. To mitigate any possible risks to the laboratory users' health conditions due to the defective power cords Inpeco released a Technical Service Bulletin (TSB) addressed only to Field Service Engineer with the procedure which has to be performed in order to prevent other cases of damaged sockets. The FSE has to check visually the appearance of the Schuko female socket. If it is intact, without any detectable deformation nor melting the FSE has to verify that the terminals are correctly crimped into each single wire. If the female socket presents alterations, the socket has to be replaced with a new one. The affected sockets will be destroyed. Customers with questions were instructed to call (+41) 91 9118 258.

Device

Inpeco SA FlexLab, Accelerator a3600 and Aptio Automation
  • Modelo / Serial
    Shucko Socket with P/N: 693822160, Model: CMSA/HETTICH - STORAGE - i2000SR, Length: 3 meters; Shucko Socket with P/N: 693822170, Model: CMSA/HETTICH - STORAGE - i2000SR, Length: 5 meters; Shucko Socket with P/N: 693822190, Model: CMSA/HETTICH - STORAGE - i2000SR, Length: 7 meters; Shucko Socket with P/N: 0C00005640, Model: CMSA/HETTICH - STORAGE - i2000SR, Length: 2 meters.  The Serial number of the impacted products globally distributed are the following: ACP.009, ACP.024, ACP.039, ACP.054, ACP.069, ACP.084, ACP.100, ACP.115 , ACP.010, ACP.025, ACP.040, ACP.055, ACP.070, ACP.085, ACP.101, ACP.116, ACP.011, ACP.026, ACP.041, ACP.056, ACP.071, ACP.086, ACP.102, ACP.117, ACP.012, ACP.027, ACP.042, ACP.057, ACP.072,ACP.087, ACP.103, ACP.118 , ACP.013, ACP.028, ACP.043, ACP.058, ACP.073, ACP.088, ACP.104, ACP.119, ACP.014, ACP.029, ACP.044, ACP.059, ACP.074, ACP.089, ACP.105, ACP.120, ACP.015, ACP.030, ACP.045, ACP.060, ACP.075, ACP.090, ACP.110, ACP.121, ACP.016, ACP.031, ACP.046, ACP.061, ACP.076, ACP.091, ACP.107, ACP.122 ,ACP.017, ACP.032, ACP.047, ACP.062, ACP.077, ACP.092, ACP.108, ACP.123 ,ACP.018, ACP.033, ACP.048, ACP.063, ACP.078, ACP.093, ACP.109, ACP.124, ACP.019, ACP.034, ACP.049, ACP.064, ACP.079, ACP.094, ACP.110, ACP.125, ACP.020, ACP.035, ACP.050, ACP.065, ACP.080, ACP.096, ACP.111, ACP.126 ,ACP.021, ACP.036, ACP.051, ACP.066, ACP.081, ACP.097, ACP.112, ACP.127 , ACP.022, ACP.037, ACP.052, ACP.067, ACP.082, ACP.098, ACP.113, ACP.128, ACP.023, ACP.038, ACP.053, ACP.068, ACP.083, ACP.099, ACP.114, ACP.129, FLX.103, FLX.0120, FLX.0131, FLX.0137, FLX.0143, FLX.0161, FLX.0166, FLX.0179, FLX.0104, FLX.0124, FLX.0134, FLX.0140, FLX.0152, FLX.0163, FLX.0175, FLX.0108, FLX.0125, FLX.0135, FLX.0141 FLX.0155, FLX.0164, FLX.0176, FLX.0115, FLX.0126, FLX.0136, FLX.0142, FLX.0158, FLX.0165, FLX.0178, AP2.0001, AP2.0004, AP2.0006, AP2.0008, AP2.0010, AP2.0012, AP2.0014, AP2.0003, AP2.0002, AP2.0005, AP2.0007, AP2.0009, AP2.0011, AP2.0013, AP2.0015, FLX.0008, FLX.0133, FLX.0149, FLX.0153, FLX.0159, FLX.0167, FLX.0170, FLX.0174, FLX.0069, FLX.0139, FLX.0150 FLX.0156, FLX.0162, FLX.0168, FLX.0172, FLX.0179, FLX.0132, FLX.0147, FLX.0151, FLX.0157, FLX.0166, FLX.0169, FLX.0173 ,FLX.0121, FLX.0138, FLX.0144, FLX.0145, FLX.0146, FLX.0148, FLX.0176 and FLX.0181.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including Texas and New York. Foreign Consignees: Germany, Italy, France, Austria and Spain.
  • Descripción del producto
    FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. || The systems consolidate multiple Analytical instruments into a unified workstation.
  • Manufacturer
    Inpeco S.A.

Manufacturer

Inpeco S.A.
  • Dirección del fabricante
    Inpeco S.A., Via San Gottardo 10, Lugano Switzerland
  • Empresa matriz del fabricante (2017)
    Inpeco Group Sa
  • Source
    USFDA