Events

Recall of Analogic

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Analogic 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
    33337
  • Event Risk Class
    Class 2
  • Event Number
    Z-0035-06
  • Event Initiated Date
    2005-09-13
  • Event Date Posted
    2005-10-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-08-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41713
  • 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
    System, Monitoring, Perinatal - Product Code HGM
  • Reason
    Unit may not power up due to faulty circuit board.
  • Action
    Analogic notified customers by letter dated 9/13/05. Distributors were requested to notify their accounts and return units for replacement of the main circuit board.

Device

Analogic
  • Model / Serial
    System Serial Numbers: FA002021 FA002022 FA002025 FA002027 FA002033 FA002020 FA002029 FA002005 FA002041 FA002044 FA002046 FA002112 FA002097 FA002117 FA002028 FA002047 FA002048 FA002118 FA002034 FA002093 FA002095 FA002116 FA002008 FA002023 FA002030 FA002031 FA002009 FA002098 FA002040 FA002092 FA002024 FA002114 FA002113 FA002115 FA002026 FA002032 FA001328
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CT, PR Foreign: Algeria, Chile,Ecudor, Mexico, South Africa, Vietnam, Russia, United Arab Emirates, Phillipines, Singapore, Korea, Malyasia
  • Product Description
    FETALGARD Lite Fetal Monitors, Model AP1S || (Single Fetus Monitoring)
  • Manufacturer
    Analogic Corporation

Manufacturer

Analogic Corporation
  • Manufacturer Address
    Analogic Corporation, Centennial Industrial park, 8 Centennial Drive, Peabody MA 01960-7902
  • Source
    USFDA