AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts.
FDA Recall Z-1487-2013 · Posted 2013-06-06
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Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeIZL
Date Initiated2013-05-15
Date Terminated2014-12-31
Product Quantity104
Reason for Recall
Customers could potentially experience intermittent, unintended and illogical movement when using the product.
Firm Action
Agfa sent an "URGENT SAFETY NOTICE" letter dated May 15, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers.
Customers were instructed if you experience unintended movement, the unit has to be taken out of operation. Please notify you Agfa service contact at once.
Please distribute this information within your facility to all those who need to be aware of this. Please complete the feedback form as soon as possible and return to us.
For further questions please call 1-877-777-2432.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide Distribution - US Nationwide including the states of AL, FL, IL, IN, IA, KY, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OR, SC, TN, VA, WV, WY and the country of 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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