Events

Recall of Device Recall Cardio Review Station (CRS)

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
    58263
  • Event Risk Class
    Class 2
  • Event Number
    Z-2552-2011
  • Event Initiated Date
    2011-03-21
  • Event Date Posted
    2011-06-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98834
  • 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
    Customer error with the angiography (xa: x-ray angiography) measurement calibration functionality within the cardiovascular review station resulted in improper calibration.
  • Action
    The firm, AGFA Healthcare, sent an "URGENT SAFETY NOTICE" letter dated March 21, 2011 via FED-EX to its customers.. The letter describes product, problem, and actions to be taken. The customers were instructed to distribute this information within their facility to all individuals who need to be aware and to complete and return the URGENT SAFETY NOTICE FEEDBACK FORM via fax to: 864-421-1664 or email. AGFA is supplying the customers with a CRS User Manual Addendum to emphasize the proper steps required to achieve an accurate measurement when using the calibration tool within CRS. Mitigation will provide the customer/end-user with awareness of the correct XA measurement calibration technique and the potential consequences if proper technique is not followed. Additionally, AGFA will offer customer training on the use of the calibration tool. This training will be provided remotely via the web at no cost. Customers were ask to register before May 1, 2011 by contacting AGFA Customer Support Center toll-free at 877-777-2432. Training sessions are from May-June 2011. If you have any questions about this matter, please contact your local AGFA HealthCare organization or the AGFA Customer Support Center at 877-777-2432.

Device

Device Recall Cardio Review Station (CRS)
  • Model / Serial
    Software versions - 2.01.B10, 2.01.B15, 2.01.B25, 2.02.B32, 2.02.B39 2.02.B40, 2.02.B43, 2.03.B16, 2.02.B23, 2.03.B26, 2.03B31.P01, 2.03.B31, 2.04.B03, 2.04.B06, 2.05.B01, 2.04.B07, 2.06.47, 2.06.47.02, 2.05.B02, 2.06.47.08, 2.06.47.08, 2.06.47.08.03, 2.06.47.02, 2.06.47.18, 2.06.47.18.01, 2.06.47.27, 2.06.47.18.02, 2.06.47.30, 2.06.47.37, 2.06.47.40, 2.07.24, 2.08.05.01, 2.07.30.01, 2.07.30.02, 2.05.03.04, 2.09.03, 2.07.30.07, 2.07.35, 2.07.24.SLEH.07, 2.09.04.02, 2.07.35.01, 2.10.06, 2.11.06, 2.05.04.05, 2.12.09, 2.13.08, 2.13.08.SU1, 2.14.03, 2.14.03.SU1, 2.15.08, 2.14.03.SU2, 2.15.08.SU3, 2.16.08, 7.4.SU3, 7.8, 7.8.SU1, and 7.8.SU2
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and country of Canada.
  • Product Description
    IMPAX CV (Cardio Vascular) || The IMPAX Cardiovascular suite is a cardiovascular information system, providing archiving, image display and modality/study specific structured reporting.
  • Manufacturer
    AGFA Corp.

Manufacturer

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