Z-0564-2014Class II

Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging

Name: Z-0564-2014 Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Creator: Ziehm Imaging Inc
Published: 2013-11-21
License: https://open.fda.gov/license/

Ziehm Imaging GmbH / initiated 2013-11-21 / Terminated / root cause: design

FDA source

Ziehm Imaging Inc began a recall of Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging on 2013-11-21. FDA classified it as Class II and gives the reason as "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". 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-0564-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-21
Posted: 2013-12-24
Terminated: 2014-06-23
Recalling firm: Ziehm Imaging GmbH
Product: Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: Ziehm Imaging sent an "URGENT RECALL NOTICE" letter dated November 22, 2013, to all affected customers. The letter identified the products the problem and the action needed to be taken by the customers. Customers were advised and instructed to: Your Model and Serial number can be found on the product label attached to the side of the mobile C-arm Stand. Our records indicate that your facility has one or more of the products listed above that are being used in your facility. Recall of the product was initiated because according to our manufacturing documentation, the referenced device installed at your facility was not equipped with an emergency stopping device for vertical travel of the c-arm imaging assembly. To fully comply with applicable standards the referenced device must be retrofitted with an emergency stopping device identification and label. The issue: According to our manufacturing documentation, the referenced device installed at your facility was not equipped with an emergency stopping device. To fully comply with applicable standards the referenced device must be retrofitted with an emergency stopping device. The manufacturer Ziehm Imaging GmbH advised customers they may continue to operate the affected device with caution until the correction has been carried out on-site. During this time Ziehm Imaging GmbH advises the operator to be aware of the following safety measures which may resolve the possibility of potentially hazardous situations by: " Operating the power-off switch located either on the C-arm Stand top panel or on the monitor cart " Removing the power cable from the wall outlet or, " Activate the push-buttons for reverse vertical movement and keeping the pushbutton pressed until patient /operator is no longer in the risk zone or the device stops Please alert all staff members working with the device to these potential hazardous situations, and familiarize them with all possibilities to resolve the hazardous situation
Quantity in commerce: 60 devices
Distribution: USA (Nationwide) Distribution including the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MT, MA, MD, MI, MN, MN, MO,MS, NC ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Hawaii.
Product codes and lots: 9209 9277 9448 9584 9655 9211 9278 9459 9585 9656 9212 9279 9475 9586 9657 9214 9315 9478 9587 9658 9216 9316 9506 9588 9659 9217 9343 9514 9633 9660 9245 9352 9530 9634 9664 9246 9358 9531 9645 9665 9255 9376 9551 9646 9666 9256 9377 9562 9647 9672 9272 9404 9571 9653 97119273 9427 9582 9654 9728

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0564-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0562-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-24
Z-0563-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-24
Z-0564-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-24
Z-0565-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-24
Z-0566-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-24
Z-0567-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-24
Z-0568-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-24

Product code OWB

K073346Class IIZiehm Vision 2Ziehm Imaging, Inc. / cleared 2008-03-21

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)