Events

Recall of CIVCO Arm Support

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Med Tec 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
    77874
  • Event Risk Class
    Class 2
  • Event Number
    Z-3083-2017
  • Event Initiated Date
    2017-08-10
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158116
  • 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
    Cradle, patient, radiologic - Product Code KXH
  • Reason
    Rigid arm supports (pn: 106015 and 106047), which were used as part of the posiboard-2 and posirest, and were distributed as pn: 106015, 106047, 106521, 106522, 109030, and 109040 between ocotober 2009 and july 2012 may have a height difference of approximately 17mm.
  • Action
    CIVCO sent an Urgent: Field Action Notice- Customer Communication letter dated July 20th, 2017. The field action notification letter was sent on August 10, 2017, by email requesting the consignee review their inventory and contact their sales representative for product replacement. Enclosed please find a notification letter which is required to be sent to all customers who received this product. Please contact your Insides Sales Representative concerning replacement instructions if you have any questions. You may reach your representative by calling CIVCO Radiotherapy, at 712-737-8688 between 8:00AM and 5:00PM CST. For further question, please call (319) 248-6537.

Device

CIVCO Arm Support
  • Model / Serial
    Codes: M181690, M194500, M203470, M213330, M216050, M142180, M143110, M149600, 0154710, M158550, M165330, M16900, M169330, M142230, M149650, M236810
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of : MI, IL and TX., and to the countries of : Greece, Australia, Czech Republic, Hungary, Norway, Brazil, Italy, Switzerland ,UK, Austria, Slovenia, Croatia, Poland, Germany, Japan, France, Netherland, Sri Lanka, Pakistan, Bangladesh, and Israel
  • Product Description
    CIVCO Arm Support, REF 106047, distributed as: || (a) Rigid Arm Support, Large, Set, Red (PN: 106047) || (b) PB2-BDLRL (PN: 109040) || (c) Rigid Adj. Arm Support, Large, Set (PN: 106048) || (d) PSR2-CF-DLRL-2P Posirest-2 (PN: 106522) || The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment.
  • Manufacturer
    Med Tec Inc

Manufacturer

Med Tec Inc
  • Manufacturer Address
    Med Tec Inc, PO Box 320, 1401 8th St SE, Orange City IA 51041-7463
  • Manufacturer Parent Company (2017)
    Roper Technologies Inc
  • Source
    USFDA