Events

Recall of Device Recall CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Boston Scientific Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71398
  • Event Risk Class
    Class 2
  • Event Number
    Z-1817-2015
  • Event Initiated Date
    2015-06-02
  • Event Date Posted
    2015-06-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137643
  • Notes / Alerts
    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.
  • Extra notes in the data
    Amplifier and signal conditioner, transducer signal - Product Code DRQ
  • Reason
    Boston scientific has received complaints indicating that, when using the blood pressure (bp) channels on the clearsign ii amplifier, the surface electrocardiogram (ecg) channels become over-written to a variable degree, with the result that it appears shifted from baseline on the system's output screen. this may, in turn, manifest as an uninterpretable ecg signal in the affected channel.
  • Action
    Boston Scientific sent an Important Field Safety Notification letter to all affected customers beginning June 3, 2015, by 24 hour overnight delivery. The letter identified the product the problem and the action needed to be taken by the customer. INSTRUCTIONS: 1. Please read carefully the Field Safety Notice letter and immediately post this information in a visible location near the product to ensure it is easily accessible to all users of the device. 2. Please complete the attached Verification Form even if you do not have any product to return. 3. When completed, please return the Verification Form to your local Boston Scientific Office to the attention of ¿Customer_Service_Fax_Number¿ on or before DATE 2015. 4. If you have products to return, and once a loaner unit is available, a Boston Scientific representative will coordinate with you to package the product being returned using a special shipping container. Your Competent Authority is being notified of this Field Safety Notice. We regret any inconvenience that this action may cause and we appreciate your understanding as we take action to ensure patient safety and customer satisfaction. If you have any questions or would like assistance with this Field Safety Notice, please contact your local Sales Representative. For further questions please call (978)-805-3200

Device

Device Recall CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System
  • Model / Serial
    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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, 55 Technology Drive, Lowell MA 01851-5203
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “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