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
ReasonOne of the dent markers from the DX-D600 dropped down from the overhead rail.
ProductDX-D600 - DXD Imaging Package
Quantity81 units
DistributionAL, CA, DC, FL, GA, HI, IL, IN, KS, LA, MA, MN, MO, NV, NJ, NM, NY, OH, OK, OR, SC, TN, TX, VA, and Canada
Initiated2016-05-02
Classified2017-04-05
Terminated2017-04-10
Recall numberZ-1738-2017
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-1738-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76840/

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