Events

Recall of Device Recall CIVCO SBRT System, REF MTSBRT001,

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Civco Medical Instruments 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
    57543
  • Event Risk Class
    Class 2
  • Event Number
    Z-3020-2011
  • Event Initiated Date
    2010-12-30
  • Event Date Posted
    2011-08-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96699
  • 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
    Table, radiographic, stationary top - Product Code IXQ
  • Reason
    Systems sold before december 2009 displayed a scale of 0-40cm going from left to right, while systems after december 2009 reversed this and were displayed as 40-0cm from left to right.
  • Action
    CIVCO issued a "FIELD SAFETY NOTIFICATION" letter dated 12/20/2010 beginning 12/30/2010, via FedEx or UPS to distributors and customers. The notification identifies the affected device, problem, and field safety corrective action. The letter states that if customers have more than one system purchased from different time periods that they should examine their systems and assess if there is any mismatch. The recalling firm will rework the system to correct the difference and send it back to the customer. To take advantage of this correction customers are advised to contact the recalling firm within thirty days of receiving the safety notification. The letter includes a response form to be completed and returned as per instructions, to indicate that the notice has been read and understood by all operators of the equipment. The letter to distributors requested that a copy of the notification letter be forward to all customers who have received this component. For assistance contact your CIVCO insides sales representative by calling CIVCO Medical Solutions, Radiation Oncology, at 800-842-8688.

Device

Device Recall CIVCO SBRT System, REF MTSBRT001,
  • Model / Serial
    M061240, M061420, M064140, M064150, M064160, M064170, M064180, M064190, M064200, M064210, M064220, M064230, M070640, M070650, M070660, M072030, M104700, M104710, M104720, M104740, M110410, M110420, M110450, M110460, M115610, M128630, M128660, M128680, M128690, M137590, M148640, M148660, M148690, M148700, M165740, M177850, M177880, M226800, M226810, M226820, M226830, M226840, M239320, M239330 and M256660
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA ( nationwide) including the state of PA. and countries of: Canada, China, England, Israel, Italy, Japan, Korea, The Netherlands, Russia, Spain, Sweden, Switzerland and Turkey.
  • Product Description
    CIVCO SBRT System, REF MTSBRT001, containing CIVCO Pro-Lok Platform, REF MTSBRT002. Firm name on label is CIVCO, Orange City, Iowa || Product Usage: The recalled product is intended to support and aid in positioning a patient during radiologic and other medical procedures.
  • Manufacturer
    Civco Medical Instruments Inc

Manufacturer

Civco Medical Instruments Inc
  • Manufacturer Address
    Civco Medical Instruments Inc, 102 1st St S, Kalona IA 52247-9589
  • Manufacturer Parent Company (2017)
    Roper Technologies Inc
  • Source
    USFDA