FDAClass IIMay 24, 2017

Ziehm Imaging solo FD Mobile Fluoroscopic C-arm recall

Ziehm Imaging solo FD Mobile Fluoroscopic C-arm

Why was Ziehm Imaging solo FD Mobile Fluoroscopic C-arm recalled?

During Ziehm Imaging GmbH FDA inspection, the label for the Collimator and X-ray Control panel was missing the manufacturer date as part of the identification for certified component

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?

S/N 52199, 52108

Product
Ziehm Imaging solo FD Mobile Fluoroscopic C-arm
Recalling firm
Ziehm Imaging Inc
Quantity
US - 2 systems
Distribution
US Distribution to the states of : FL and CA. No devices listed in this recall where distributed any foreign /military/government consignees from the U.S.A.
Recall date
May 24, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls