FDAClass IIAugust 31, 2016

Ziehm Vision2 recall

Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging

Why was Ziehm Vision2 recalled?

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.

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?

Serial #'s: 91760 and 91770.

Product
Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging
Recalling firm
Ziehm Imaging Inc
Quantity
2 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.
Recall date
August 31, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls