FDAClass IIJanuary 1, 2014

Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray recall

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

Why was Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Recalling firm
Ziehm Imaging Inc
Quantity
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.
Recall date
January 1, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls