Events

Recall of Zoll Medical

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zoll Medical 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
    29959
  • Event Risk Class
    Class 2
  • Event Number
    Z-1472-04
  • Event Initiated Date
    2004-08-02
  • Event Date Posted
    2004-09-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34847
  • 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
    Hepatitis Viral B Dna Detection - Product Code MKT
  • Reason
    Visual sreen display and audible prompt may not advise to 'press shock'.
  • Action
    Zoll Medical notified consignees by letter on 8/2/04 via Certified Mail. Users are advised of the problem and the softtware upgrade.

Device

Zoll Medical

Manufacturer

Zoll Medical Corporation
  • Manufacturer Address
    Zoll Medical Corporation, 269 Mill Rd, Chelmsford MA 01824-4105
  • Source
    USFDA