Events

Recall of Device Recall AccuSeed DS Digital Stepper

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Computerized Medical Systems 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
    36665
  • Event Risk Class
    Class 2
  • Event Number
    Z-0221-2007
  • Event Initiated Date
    2006-11-09
  • Event Date Posted
    2006-11-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-11-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49115
  • 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
    radioactive seed placement system - Product Code ITX
  • Reason
    The in/out adjustment knob can be over-turned, ultimately causing the incorrect placement of radioactive seeds in the patient.
  • Action
    The recalling firm issued letters dated 11/9/06 via regular mail. The letter informs the customer of the problem and includes an advisory notice instructing them to perform a test prior to each use. If the system does not function correctly, it can still be used safely in a manual mode until it can be returned for repair. A questionnaire was enclosed that will facilitate the firm in prioritizing repairs and retrofits. After the questionnaire is reviewed, the firm will contact the customer for further information regarding their facilities use of the device. This letter was also issued to the CMS customer support departments in Japan, China, and Europe, who will notify the foreign customers and prioritize their returns for repair.

Device

Device Recall AccuSeed DS Digital Stepper
  • Model / Serial
    All Model #DS300 steppers
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Australia, Japan, China, France, Germany and Brazil.
  • Product Description
    AccuSeed DS Digital Stepper, an accessory to a prostate radiation treatment planning system. Model #DS300
  • Manufacturer
    Computerized Medical Systems Inc

Manufacturer

Computerized Medical Systems Inc
  • Manufacturer Address
    Computerized Medical Systems Inc, 1145 Corporate Lake Dr Ste 100, Saint Louis MO 63132-1716
  • Source
    USFDA