Recall of Device Recall QRS Card 12 Lead Resting & Stress ECG Machine with Blue Tooth (wireless) interface

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Pulse Biomedical Inc.

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
    37642
  • Event Risk Class
    Class 2
  • Event Number
    Z-0716-2007
  • Event Initiated Date
    2007-03-05
  • Event Date Posted
    2007-04-04
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2007-08-29
  • Event Source
    USFDA
  • Event Source URL
  • 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
    electrocardiogram machine - Product Code LOS
  • Reason
    No 510(k) marketing clearance for the product.
  • Action
    On 3/5/07, the recalling firm telephoned their customers to inform them of the problem and the need to return to the product. As a follow up to the telephone calls a letter dated 3/5/07 was sent via certified mail.

Device

  • Model / Serial
    Serial numbers: 3405AB0118E, 3605AU0168O, 3605AU0184O, 2505AB0068E, 2306AU0600E-BT, 2406AU0610E-BT, 2306AU0601E-BT, and 2707AU0641E-BT.
  • Distribution
    The product was shipped to four direct customers in CA, NY, TN and US military (Cuba). The product was also shipped to Chile, Greece, and the Netherlands
  • Product Description
    QRS Card 12 Lead Resting & Stress ECG Machine with Blue Tooth (wireless) interface. Cardiology Suite (CS 4.0) Software is used with the machine.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Pulse Biomedical Inc, 1305 Catfish Ln, Norristown PA 19403-2500
  • Source
    USFDA