Events

Recall of Civco Belly Board, REF 126000

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
    66591
  • Event Risk Class
    Class 2
  • Event Number
    Z-0803-2014
  • Event Initiated Date
    2013-10-25
  • Event Date Posted
    2014-01-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122662
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Reason
    Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.
  • Action
    Civco Medical Instruments Inc sent a FIELD SAFETY NOTIFICATION letter dated October 28, 2013 via UPS to their customers. The notification identified the affected device, problem, and field safety corrective action. The letter describes how customers can check to see whether the scales on their device are out of alignment. The letter states CIVCO will rework the system to correct the difference. For questions contact sales representative at CIVCO Medical Solutions, Radiation Oncology at 800-842-8688 or 712-737-8688.

Device

Civco Belly Board, REF 126000
  • Model / Serial
    Lot#'s: M551490 and M550150
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, MA, MD, MI, MN, MT, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, and WV. Foreign distribution was made to Brazil, Canada, Chile, Czech Republic, France, Germany, Iraq, Israel, Italy, Japan, Malaysia, Saudi Arabia, Slovenia, South Korea, Spain, Turkey, and United Arab Emirates.
  • Product Description
    Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion, REF 126000, packaged 1 per box. || Product Usage: This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region.
  • 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