Z-1893-2017Class II

Ziehm Imaging solo FD Mobile Fluoroscopic C-arm

Name: Z-1893-2017 Ziehm Imaging solo FD Mobile Fluoroscopic C-arm
Creator: Ziehm Imaging Inc
Published: 2017-02-23
License: https://open.fda.gov/license/

Ziehm Imaging GmbH / initiated 2017-02-23 / Terminated / root cause: labeling and UDI

FDA source

Ziehm Imaging Inc began a recall of Ziehm Imaging solo FD Mobile Fluoroscopic C-arm on 2017-02-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1893-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-23
Posted: 2017-05-17
Terminated: 2019-12-11
Recalling firm: Ziehm Imaging GmbH
Product: Ziehm Imaging solo FD Mobile Fluoroscopic C-arm
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: 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
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Ziehm Imaging will bring defect into compliance: Customer Precautions: Therefore, as there is no identifiable risk to patients, users or third parties, the manufacturer Ziehm Imaging GmbH advises customers they may continue to operate the affected device until the labeling materials can be remediated. Please alert all staff members working with the device to this notification. Remedy: 1. You will contact customers and initiate the actions to correct the failure to comply issues. 2. You will affix the identification labels to the collimator and x-ray control panel. 3. You will replace the existing user manual with one that reflects the reference images of the labels with manufacturer date. If there are any questions or concerns regarding this product safety issue, please do not hesitate to contact our National Service Team for further information at Ziehm Imaging, Inc. Toll-Free: (866) 949-4346, Fax: (866) 839-7893 or E- Mail: [email protected]
Quantity in commerce: US - 2 systems
Distribution: US 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.
Product codes and lots: S/N 52199, 52108

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1893-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1893-2017	Class II	Terminated	FDA Mandated	2017-05-24	2017-05-16

Product code OWB

K161976Class IIZiehm Solo FDZiehm Imaging GmbH / cleared 2016-10-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)