Events

Recall of Device Recall Rita Thermopads

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Rita Medical Systems.

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
    29383
  • Event Risk Class
    Class 2
  • Event Number
    Z-1076-04
  • Event Initiated Date
    2004-06-16
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-10-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33646
  • 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
    Electrode, Electrosurgical - Product Code JOS
  • Reason
    Inaccurate temperature readings may be displayed by the device, actual temperature could be 2.5-3 degrees c higher than displayed.
  • Action
    Each hospital that has been shipped the devices will receive a recall letter during the week of june 21, 2004 with materials for return shipping. Field representatives will receive notice of the recall, and will return any unused devices and document consumed devices.

Device

Device Recall Rita Thermopads
  • Model / Serial
    Lot codes affected: Y110503-1 and Y103003-2. 510k number : k031926 Contract manufacturer, Katecho, Inc, registration number 1932007
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was shipped to 18 field representatives and 87 customers (hospitals and medical centers
  • Product Description
    Dispersive Electrodes packaged in an 8x10 plastic container.
  • Manufacturer
    Rita Medical Systems

Manufacturer

Rita Medical Systems
  • Manufacturer Address
    Rita Medical Systems, 967 N Shoreline Blvd, Mountain View CA 94043-1932
  • Source
    USFDA