Z-0591-2012

Agfa Computed Radiography Systems with DX-G Digitizer. DX-G Digitizers haved the same intended use as the...

Name: Z-0591-2012 Agfa Computed Radiography Systems with DX-G Digitizer. DX-G Digitizers haved the same intended use as the...
Creator: AGFA Corp.
Published: 2011-12-06
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2011-12-06 / Terminated / root cause: software

FDA source

AGFA Corp. began a recall of 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... on 2011-12-06. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0591-2012
Status: Terminated
Initiated: 2011-12-06
Posted: 2012-01-11
Terminated: 2012-04-11
Recalling firm: AGFA Healthcare Corp.
Product: 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.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 125
Distribution: 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.
Product codes and lots: Model No. 5170/100

Product code MQB

K092238Class IIAgfa Computed Radiography Systems with Dx-G DigitizersAgfa Healthcare N.V. / cleared 2009-08-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)