Events

Recall of Device Recall ANSAR ANX3.0 Autonomic Monitor system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ansar Group, Inc. Dba Ansar Medical Technologies, 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
    68735
  • Event Risk Class
    Class 2
  • Event Number
    Z-2268-2014
  • Event Initiated Date
    2014-07-01
  • Event Date Posted
    2014-08-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128581
  • 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
    Monitor, cardiac (incl. Cardiotachometer and rate alarm) - Product Code DRT
  • Reason
    The blood pressure (bp) circuit occasionally fails to inflate the blood pressure cuff and the bp circuit fails to activate, resulting in no bp measured.
  • Action
    Recall notification letters sent to customers on July 8-9, 2014 by registered mail.

Device

Device Recall ANSAR ANX3.0 Autonomic Monitor system
  • Model / Serial
    ANX 3.0 unit numbers: 193 through 1203.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. || The ANX 3.0 system is comprised of these components. 1. Patient Physiological Monitor, 2. Laptop Computer, 3. Stand w/wheels, 4. Patient cables, 5. Software components (Respiratory and Cardiac Spectral Frequency Signal Processor). || The different monitor components that can be used in the system are one of the following per system are as follows: Patient Physiological Monitors used: CJPS Vital Pro, Zoe Medical Nightingale Monitoring system, Ivy Biomedical model 405P, Software components: Ansar ANS C 3000. || The device is also referred to as the ANS-C3000.
  • Manufacturer
    Ansar Group, Inc. Dba Ansar Medical Technologies, Inc

Manufacturer

Ansar Group, Inc. Dba Ansar Medical Technologies, Inc
  • Manufacturer Address
    Ansar Group, Inc. Dba Ansar Medical Technologies, Inc, 240 S 8th St, Philadelphia PA 19107-5728
  • Manufacturer Parent Company (2017)
    Ansar Group Inc.
  • Source
    USFDA