Events

Recall of RITA

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
    27500
  • Event Risk Class
    Class 2
  • Event Number
    Z-0087-04
  • Event Initiated Date
    2003-10-06
  • Event Date Posted
    2003-11-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-05-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29976
  • 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
    Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
  • Reason
    The product displays inaccurate temperature readings, patient skin burns can occur before getting to higher temperature reading.
  • Action
    On 10/6/03, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected devices and providing instructions on the recall.

Device

RITA
  • Model / Serial
    Lot numbers: Y072103-3, Y082003
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was released for distribution to 66 consignees in US. The product received nationwide distribution. The recall was appropriately extended to the user level; i.e., the hospitals that received the recalled product. There were no shipments to foreign or Canadian distribution, however, it includes one military distribution: Wilford Hall Medical Center, 2200 Berquist Dr., 31, Lackland AFB, TX 78236.
  • Product Description
    RITA brand ThermoPad, Electrosurgical RF Generator and accessories || Part Number: 700-102649
  • Manufacturer
    Rita Medical Systems

Manufacturer

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