Events

Recall of Product is a CALYSTO Series IV Physio-monitoring & Information System model # M-S0053.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Witt Biomedical 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
    33936
  • Event Risk Class
    Class 2
  • Event Number
    Z-0305-06
  • Event Initiated Date
    2005-09-16
  • Event Date Posted
    2005-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42762
  • 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, Physiological, Patient (Without Arrhythmia Detection Or Alarms) - Product Code MWI
  • Reason
    Customer complained that a boom monitor came off the boom. no patient or user injury was associated with the incident.
  • Action
    Consignees will be notified of recall by phone, the firm will use a phone script.

Device

Product is a CALYSTO Series IV Physio-monitoring & Information System model # M-S0053.
  • Model / Serial
    Serial numbers 970424D to 200501499.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Products were distributed to approximately 672 medical facilities throughout the United States.
  • Product Description
    Product is a CALYSTO Series IV Physio-monitoring & Information System model # M-S0053.
  • Manufacturer
    Witt Biomedical Corporation

Manufacturer

Witt Biomedical Corporation
  • Manufacturer Address
    Witt Biomedical Corporation, 305 North Drive, Melbourne FL 32934-9201
  • Source
    USFDA