Events

Recall of ADC Solo & Initia CR 1000, Path Speed CR SP1001, Centricity CR SP1001 and Centricity CR SP 100, image digitizer, components in Agfa''s computed radiography product line.

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
    34087
  • Event Risk Class
    Class 2
  • Event Number
    Z-0352-06
  • Event Initiated Date
    2005-11-18
  • Event Date Posted
    2006-01-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43095
  • 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, X-Ray, Stationary - Product Code KPR
  • Reason
    Users of affected systems may experience a loss of images, the need to repeat the imaging procedure and possibly a short delay in diagnosis.
  • Action
    Consignees were notified by letter on/about December 1, 2005.

Device

ADC Solo & Initia CR 1000, Path Speed CR SP1001, Centricity CR SP1001 and Centricity CR SP 100, i...
  • Model / Serial
    Serial Numbers: ADC Solo: Units with Serial numbers les than 4748, Initia CR1000, Path Speed CR SP1001, Centricity CR SP1001 and Centricity CR SP100: all serial numbers are considered affected unless they have been upgraded to software version SOL_2205 or later.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    ADC Solo & Initia CR 1000, Path Speed CR SP1001, Centricity CR SP1001 and Centricity CR SP 100, image digitizer, components in Agfa''s computed radiography product line.
  • Manufacturer
    AGFA Corp.

Manufacturer

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