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.
FDA Recall Z-0591-2012 · Posted 2012-01-11
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Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeMQB
Date Initiated2011-12-06
Date Terminated2012-04-11
Product Quantity125
Reason for Recall
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.
Firm Action
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.
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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