Events

Recall of CARESTREAM DIRECTVIEW CR

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Carestream Health, 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
    69703
  • Event Risk Class
    Class 2
  • Event Number
    Z-0820-2015
  • Event Initiated Date
    2014-10-30
  • Event Date Posted
    2014-12-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131396
  • 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
    System, image processing, radiological - Product Code LLZ
  • Reason
    Reduced mammographic image quality when attempting to print true size multi-format images.
  • Action
    The firm, Carestream Health Inc., sent an "URGENT: Medical Device Recall" notice dated October 28, 2014 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to use the one-up printing option rather the multi-format printing option if a hard copy is required. Carestream has a software update that will address this issue. A Carestream service representative will contact all customers to schedule a visit to correct this software issue. If you have any questions or concerns or would like to request the installation of the previous software version that does not have this issue, please contact the Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24 hour basis. Outside of the U.S. please call your local service support number.

Device

CARESTREAM DIRECTVIEW CR
  • Model / Serial
    Software Verions: 1) 5.7.312.27 , 2) 5.7.312.27, 3) 5.7.312.2031
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US distribution to states of : NY, OH, and NC; and countries of: Argentina, Brazil, China, Chile, Colombia, France, Greece, Hong Kong, India, Japan, Korea, Mexico, Peru, Spain, Taiwan, and Thailand.
  • Product Description
    CARESTREAM DIRECTVIEW CR Software || Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
  • Manufacturer
    Carestream Health, Inc.

Manufacturer

Carestream Health, Inc.
  • Manufacturer Address
    Carestream Health, Inc., 1049 W Ridge Rd, Rochester NY 14615-2731
  • Manufacturer Parent Company (2017)
    ONEX Corp
  • Source
    USFDA