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.
Customer error with the angiography (xa: x-ray angiography) measurement calibration functionality within the cardiovascular review station resulted in improper calibration.
조치
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.
Worldwide distribution: USA (nationwide) and country of Canada.
제품 설명
IMPAX CV (Cardio Vascular) || The IMPAX Cardiovascular suite is a cardiovascular information system, providing archiving, image display and modality/study specific structured reporting.