RegWardenFDA facility compliance records
Recall

Class II — AGFA Healthcare Corp.

Recalling firmAGFA HEALTHCARE N.V.
Registered facilityView this company's 4 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonWhen using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge of the unit to the ground may occur.
ProductAGFA DX-D 100 is a mobile digital radiography x-ray system
Quantity233 units
DistributionUS Distribution to the states of : AL, CA, DC, FL, GA, IL, IA, KY, LA, MD, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OK, OR, SC, TN, TX, VA, WV, WI and WY.
Initiated2015-05-29
Classified2015-06-10
Terminated2017-01-18
Recall numberZ-1745-2015
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 Healthcare Corp. (Z-1745-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71393/

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