RegWardenFDA facility compliance records
Recall

Class II — AGFA Corp.

Recalling firmAgfa N.V.
Registered facilityView this company's 2 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonCustomers could potentially experience intermittent, unintended and illogical movement when using the product.
ProductAGFA 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.
Quantity104
DistributionWorldwide 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
Initiated2013-05-15
Classified2013-06-06
Terminated2014-12-31
Recall numberZ-1487-2013
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — AGFA Corp. (Z-1487-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65223/

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