Events

Recall of Device Recall Drystar Mammo

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by AGFA 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
    60762
  • Event Risk Class
    Class 3
  • Event Number
    Z-0916-2012
  • Event Initiated Date
    2010-03-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106413
  • 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
    Labeling problem.
  • Action
    The firm, AGFA Corporation spoke to the customer directly via telephone concerning the mislabeled affected products. The firm also contacted the customer via e-mail on April 13, 2011 explaining the outcome of the customer complaint. Replacement product was sent to the customer.

Device

Device Recall Drystar Mammo
  • Model / Serial
    ABC Code: EWCAK, size 8x10 inch Manufacturing lot: Emulsion Number: 36760074, cutting plan: B1AW1
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product distributed in Florida.
  • Product Description
    Drystar Mammo. || Display of Mammographic images.
  • Manufacturer
    AGFA Corp.

Manufacturer

AGFA Corp.
  • Manufacturer Address
    AGFA Corp., 10 S Academy St, Greenville SC 29601-2632
  • Source
    USFDA