FDAClass IIMay 11, 2016

Smart CR Digital Computed Radiography System recall

Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU

Why was Smart CR Digital Computed Radiography System recalled?

Reports of failure of the device's power supply.

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?

All serial numbers.

Product
Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU
Recalling firm
Fujifilm Medical Systems U.S.A., Inc.
Quantity
2,062 devices
Distribution
Nationwide Distribution.
Recall date
May 11, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls