Events

Recall of AutoPulse Resuscitation System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zoll Circulation, 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
    62950
  • Event Risk Class
    Class 2
  • Event Number
    Z-0658-2013
  • Event Initiated Date
    2012-08-08
  • Event Date Posted
    2013-01-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112116
  • 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
    Compressor, cardiac, external - Product Code DRM
  • Reason
    Complaints associated with an unexpected stop in autopulse compressions.
  • Action
    Zoll sent Customer Notification letters dated August 8, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Zoll Technical Support Line at 1 (800) 348-9011 for further assistance.

Device

AutoPulse Resuscitation System
  • Model / Serial
    all
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution.
  • Product Description
    AutoPulse Resuscitation System Model 100, || Mfg by:Zoll Circulation || Sunnyvale, CA. || The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.
  • Manufacturer
    Zoll Circulation, Inc.

Manufacturer

Zoll Circulation, Inc.
  • Manufacturer Address
    Zoll Circulation, Inc., 650 Almanor Ave, Sunnyvale CA 94085-3513
  • Manufacturer Parent Company (2017)
    Asahi Kasei Corp.
  • Source
    USFDA