Device Recall CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System

  • Modèle / numéro de série
    Catalog number 2002021: lot numbers: EPYL0080, EPYL0118, EPZA0061, EPZA0072, EPZA0073, EPZA0074, EPZB0043, EPZC0019, EPZC0026, EPZC0027; Catalog number 2002022: lot numbers: EPYL0031, EPYL0032, EPYL0033, EPYL0034, EPYL0035, EPYL0036, EPYL0037, EPYL0038, EPYL0039, EPZA0062, EPZA0063, EPZA0079, EPZA0080, EPZB0049, EPZB0050, EPZB0051, EPZB0052, EPZB0056, EPZB0057, EPZB0058, EPZB0059, EPZB0065, EPZB0066, EPZB0067, EPZB0116, EPZB0117, EPZB0118, EPZC0018, EPZC0020, EPZC0021, EPZC0022, EPZC0023,EPZC0025, EPZD0013, EPZD0014, EPZD0015, EPZD0016, EPZD0017; Catalog number: 2002023: lot numbers: EPYL0082, EPYL0083, EPZA0064, EPZB0085, EPZB0119, EPZC0024, EPZD0018, EPZD0019, EPZD0020; Catalog number: 2002024; lot numbers: EPYL0082, EPYL0083, EPZA0064, EPZB0085, EPZB0119, EPZC0024, EPZD0018, EPZD0019, EPZD0020.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    No US distribution. Worldwide Distribution to the countries of : Austria, Belgium, France, Germany, Great Britain, Greece, Italy, Netherlands, Poland, Romania, South Africa, Spain, Switzerland and Turkey.
  • Description du dispositif
    CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08. The channel numbers in the amplifier are as follows: || Material number: H30120020210 - 40 Channel CLEARSIGN II Amplifier, catalog number 2002021; || Material number: H30120020220 80 Channel CLEARSIGN II Amplifier, catalog number 2002022; || Material number: H30120020230 120 Channel CLEARSIGN II Amplifier, catalog number 2002023; || Material number: H30120020240 160 Channel Clearsign II Amplifier, catalog number 2002014. || The CLEARSIGN II Amplifier is intended to amplify and condition electrocardiographic signals of biologic origin and pressure transducer input, transmitting this information to a host computer (the LABSYSTEM PRO EP Recording System) that can record and display the information
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Boston Scientific Corporation, 55 Technology Drive, Lowell MA 01851-5203
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA