FDAClass IIMarch 18, 2015

Juno DFR X-ray system recall

Juno DFR X-ray system

Why was Juno DFR X-ray system recalled?

The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality

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?

P/N 709020

Product
Juno DFR X-ray system
Recalling firm
Villa Radiology Systems LLC
Quantity
30 units distributed in the US
Distribution
US Distribution to the states of: AZ, AL, CA, CO, CT, DC, FL, IA, IL, IN, MI, MD, MS, MA, MO, NY, OH, PA, UT, TN and TX.
Recall date
March 18, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls