Events

Recall of Device Recall Radiomat B Plus, Radiomat M Plus, radiomat G Plus, Radiomat SG, RXB and Curix UVG Plus

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

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
    68844
  • Event Risk Class
    Class 3
  • Event Number
    Z-2178-2014
  • Event Initiated Date
    2014-07-16
  • Event Date Posted
    2014-08-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128843
  • 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
    Film, radiographic - Product Code IWZ
  • Reason
    Some sheets of the medical screen film are fogged.
  • Action
    On July 16, 2014, an "URGENT FIELD SAFETY NOTICE" letter was sent to the US and Canadian dealers (consignees). The letter described the safety alert and the request to quarantine affected product. Acknowledgment, via FAX-Back or email, that the information was received and understood was requested from the dealers. A customer Urgent Field Safety Notice was also provided to those dealers who had shipped affected product to end users so that it could be sent to their customers.

Device

Device Recall Radiomat B Plus, Radiomat M Plus, radiomat G Plus, Radiomat SG, RXB and Curix UVG ...
  • Model / Serial
    Lot Batch No. 79350052, 79380052, 79390074, 79400066, 79410063
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution and US Nationwide in the states of AL, AZ, CA, FL, IL, LA, MI, MN, MS, NE, NH, NJ, NC and country of Canada
  • Product Description
    Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF || Product Usage: Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides of the film, with a radiotransparent material coated on one or both sides of the film, with a photographic emulsion intended to record images during diagnostic radiologic procedures.
  • Manufacturer
    AGFA Healthcare Corp.

Manufacturer

AGFA Healthcare Corp.
  • Manufacturer Address
    AGFA Healthcare Corp., 10 S Academy St, Greenville SC 29601-2632
  • Manufacturer Parent Company (2017)
    Agfa-Gevaert NV
  • Source
    USFDA