Z-2639-2016Class II

Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging

Name: Z-2639-2016 Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging
Creator: Ziehm Imaging Inc
Published: 2016-04-15
License: https://open.fda.gov/license/

Ziehm Imaging GmbH / initiated 2016-04-15 / Terminated / root cause: design

FDA source

Ziehm Imaging Inc began a recall of Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging on 2016-04-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2639-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-15
Posted: 2016-08-25
Terminated: 2019-07-18
Recalling firm: Ziehm Imaging GmbH
Product: Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: Ziehm Imaging, Inc planned action to bring these defects into compliance: 1. You will contact customers and initiate a software update to correct the defects. 2. You will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance. For further questions, please call (866) 949-4346.
Quantity in commerce: 31 devices
Distribution: US Distribution including Puerto Rico and to the states of :FL, GA, VA,MA. ME, MI, NY, NJ, PA, RI, IL, TX, AZ, CA, NV, UT, and WA.
Product codes and lots: Serial #'s 20628, 20657, 20658, 20659, 20660, 20671, 20672, 20678, 20679, 20680, 20681, 20682, 20683, 20684, 20685, 20686, 20687, 20712, 10713, 20714, 20715, 20717, 20718, 20722, 20723, 20724, 20725, 20726, 20772, 20793, and 20794.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2639-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2639-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-25
Z-2640-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-25
Z-2641-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-25
Z-2642-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-25
Z-2643-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-25
Z-2644-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-25

Product code OWB

K142740Class IIZiehm Vision RFD 3DZiehm Imaging GmbH / cleared 2015-04-06

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)