RegWardenFDA facility compliance records
Company

ZIEHM IMAGING GMBH

3 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2013: 1 recalls; 2016: 1 recalls; 2017: 1 recalls1’13’14’151’161’17’18’19’20’21’22’23’24’25’26
  • Recalls (3)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2017-02-23
    During Ziehm Imaging GmbH FDA inspection, the label for the Collimator and X-ray Control panel was missing the manufacturer date as part of the identification for certified component
  • Class IITerminated2016-04-15
    Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.
  • Class IITerminated2013-11-21
    Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “ZIEHM IMAGING GMBH — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9019776-ziehm-imaging-gmbh/

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