Ziehm Imaging Inc: Medical Device Recall in 2014 - (Recall #: Z-0564-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.
Product Description:

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

Product Classification:

Class II

Date Initiated: November 21, 2013
Date Posted: January 1, 2014
Recall Number: Z-0564-2014
Event ID: 66976
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.

Status: Terminated
Product Quantity: 60 devices
Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated