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Recall

Class II — Ziehm Imaging Inc

Recalling firmZIEHM IMAGING GMBH
Registered facilityZIEHM IMAGING GMBH (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonDuring 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
ProductZiehm Imaging solo FD Mobile Fluoroscopic C-arm
QuantityUS - 2 systems
DistributionUS Distribution to the states of : FL and CA. No devices listed in this recall where distributed any foreign /military/government consignees from the U.S.A.
Initiated2017-02-23
Classified2017-05-16
Terminated2019-12-11
Recall numberZ-1893-2017
InitiationFDA Mandated

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 — Ziehm Imaging Inc (Z-1893-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77030/

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