RegWardenFDA facility compliance records
Facility

ZIEHM IMAGING GMBH

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

Activity by year

FDA actions on record by year2013: 1 recalls; 2016: 1 recalls; 2017: 1 recalls, 1 inspections1’13’14’151’162’17’18’19’20’21’22’23’24’25’26
  • Recalls (3)
  • Inspections (1)

Devices registered here (2)

  • System, X-Ray, Fluoroscopic, Image-Intensified
    Product code JAA (opens in a new tab) · Class II · Radiology · 21 CFR 892.1650
  • Interventional Fluoroscopic X-Ray System
    Product code OWB (opens in a new tab) · Class II · Radiology · 21 CFR 892.1650

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.

FDA inspections (1)

  • VAI2017-02-17
    Voluntary Action Indicated · Compliance: Devices; Radiation Control and Health Safety Act · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

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

Cite this record

RegWarden. “ZIEHM IMAGING GMBH (FEI 3005430103) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005430103-ziehm-imaging-gmbh/

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