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U.S. Department of Health and Human Services

Class 2 Device Recall DXG Digitizer

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  Class 2 Device Recall DXG Digitizer see related information
Date Initiated by Firm December 06, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on April 11, 2012
Recall Number Z-0591-2012
Recall Event ID 60625
510(K)Number K092238  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
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.
Code Information Model No. 5170/100
Recalling Firm/
Manufacturer
AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Debbie Huff
864-421-1815
Manufacturer 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.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = AGFA HEALTHCARE N.V.
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