Events

Recall of Device Recall Zoll Auto Pulse 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
    58099
  • Event Risk Class
    Class 3
  • Event Number
    Z-1904-2011
  • Event Initiated Date
    2008-01-28
  • Event Date Posted
    2011-04-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98342
  • 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 of batteries discharging prematurely and that during use the auto pulse units would cease operating (providing compressions).
  • Action
    The firm, Zoll Circulation Inc., initiated a Corrective and Preventive Action Report on January 28, 2009. According to the firm, the customers were contacted by telephone calls and were provided with a Battery Maintenance program. For further questions you may call (408) 541-2140 ext.341.

Device

Device Recall Zoll Auto Pulse Resuscitation System
  • Model / Serial
    Model 100; AutoPulse product number 8700-0700-xx AutoPulse 1.5G; AutoPulse Battery Part Number 8799-0702-xx
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- including, VA, NY, OH, IN, MO, UT, FL, NC, ME, WA, SD, NM, PA, MS, ID, TX, GA, CA, CO, IL, AR, WV, TN, OR, and KS.
  • Product Description
    Zoll Auto Pulse Resuscitation System; Zoll Circulation Inc., Sunnyvale, CA 94085 || Cardiac Compressor used as an adjunct to manual CPR. Use of AutoPulse is intended to reduce the impact of rescuer fatigue and enable rescuer to address other patient needs.
  • 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