Events

Recall of MIRA CR4050 Finger Probe

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mira, 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
    55818
  • Event Risk Class
    Class 2
  • Event Number
    Z-1918-2010
  • Event Initiated Date
    2010-04-08
  • Event Date Posted
    2010-06-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91949
  • 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
    Cryophthalmic Unit - Product Code HPS
  • Reason
    Devices distributed without an approved 510(k).
  • Action
    Mira contacted accounts by email between 4/08/10-05/21/10 requesting return of inventory.

Device

MIRA CR4050 Finger Probe
  • Model / Serial
    SER# W04643-1 SER# 45-1109 SER# 44-1109 One Unit no Serial Number
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including the state of NY and the countries of Israel and Italy.
  • Product Description
    MIRA CR4050 12mm Finger Probe || 12mm surface x 27mm Length || Intended for the destruction of tumors.
  • Manufacturer
    Mira, Inc.

Manufacturer

Mira, Inc.
  • Manufacturer Address
    Mira, Inc., 414 Quaker Hwy, Uxbridge MA 01569
  • Manufacturer Parent Company (2017)
    Mira Inc.
  • Source
    USFDA