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.
Occasionally images can be lost or sent to an incorrect folder or the digitizer may stop either during startup or during a cassette scan cycle.
조치
Agfa HealthCare sent a 'URGENT SAFETY NOTICE" letter dated December 6, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Agfa Service will contact your facility and schedule a software upgrade if this has not already been performed. Please complete the attached feedback form as soon as possible and fax it to 864-421-1662.
If you have any questions about this matter, please contact your local Agfa HealthCare Service at 877-777-2432.
Worldwide Distribution-- USA (nationwide) including the states of AZ, CA, CO, FL, GA, HI, IL, IN, KS, LA, ME, MI, MN, MO, NE, NH, NJ, NY, OH, OK, PA, SD, TX, VA, WA, WI and WV, and Canada.
제품 설명
Agfa Computed Radiography Systems with DX-G Digitizer. || DX-G Digitizers haved the same intended use as the predicate devices. they are intended to use in providing diagnostic images to aid the physician with diagnosis. DX-G Digitizers provide the ability to use both standand needle phosphor image plates and can be used with either Musica or Musica 2. In the US, Agfa's Computed Radiography Systems with DX-G Digitizers are not intended for use in mammography.