Events

Rappel de Inpeco SA FlexLab, Accelerator a3600 and Aptio Automation

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Inpeco S.A..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    75513
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0587-2017
  • Date de mise en oeuvre de l'événement
    2016-10-04
  • Statut de l'événement
    Completed
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150626
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Electrode, ion specific, potassium - Product Code CEM
  • Cause
    Inpeco received several notifications from the field about burnt schuko sockets. the customers reported that some smoke was seen coming from the damaged sockets.
  • Action
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including Texas and New York. Foreign Consignees: Germany, Italy, France, Austria and Spain.
  • Description du dispositif
    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.
  • Adresse du fabricant
    Inpeco S.A., Via San Gottardo 10, Lugano Switzerland
  • Société-mère du fabricant (2017)
    Inpeco Group Sa
  • Source
    USFDA