Events

Recall of Device Recall Pinnacle3

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

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
    28478
  • Event Risk Class
    Class 2
  • Event Number
    Z-0913-04
  • Event Initiated Date
    2004-03-03
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-02-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32102
  • 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
    System, Planning, Radiation Therapy Treatment - Product Code MUJ
  • Reason
    A software defect, relating to the motorized wedge functionality when using an elekta linear accelerator, can result in incorrect dose delivery to the patient. also, dose delivery in the wrong location may occur when using a elekta leksell headframe.
  • Action
    A notification dated March 3, 2004 was sent to the customers. The notification gave recommendations for avoiding the problem and stated that updated software would be provided when it becomes available. Firm representatives made follow-up telephone calls to the consignees.

Device

Device Recall Pinnacle3
  • Model / Serial
    Version 7.0e, Rev. A
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The recalled products were shipped to consignees located nationwide the United States and in Australia, Canada, China, and Korea.
  • Product Description
    Pinnacle3 Radiation Therapy Planning System, Version 7.0e CD, Part Number Part # 9104-2011A Rev. A
  • Manufacturer
    ADAC Laboratories

Manufacturer

ADAC Laboratories
  • Manufacturer Address
    ADAC Laboratories, 6400 Enterprise Ln Ste 201, Madison WI 53719-1138
  • Source
    USFDA