Events

Recall of Device Recall SCOPIX LR 5200P Laser Imagers

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
    27844
  • Event Risk Class
    Class 2
  • Event Number
    Z-0207-04
  • Event Initiated Date
    2003-11-25
  • Event Date Posted
    2003-12-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-10-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30627
  • 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
    Camera, Multi Format, Radiological - Product Code LMC
  • Reason
    The gs1 circuit board may fail resulting in smoke or fire.
  • Action
    Consignees were notified by letter on 11/25/2003. They were informed of the problem and were advised, if they have the affected type and serial number, to contact the Agfa service representative to arrange for repair. The firm intends to install a modified circuit board on each machine remaining in operation at customer locations. Consignees were instructed to discontinue use of the device immediately and to disconnect the unit from the power supply if any odor of smoke or fire is detected. They were urged to complete the Customer Acknowledgement form included with the letter and return it in the enclosed postage paid envelope.

Device

Device Recall SCOPIX LR 5200P Laser Imagers
  • Model / Serial
    Model number LR 5200P, Catalog number: EMQT S000, Types: 8394/600, Serial numbers: 4000 through 5266.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The units were distributed to hospitals and other health facilities located nationwide
  • Product Description
    SCOPIX ¿ LR 5200P¿ Laser Imagers, Type 8394/600, serial numbers between 4000 and 5266.
  • Manufacturer
    AGFA Corp.

Manufacturer

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