FDAClass IIJanuary 22, 2020

Kodak DirectView DR3000/3500 - Product Usage recall

Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for examination of…

Why was Kodak DirectView DR3000/3500 - Product Usage recalled?

Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm.

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?

DR3000: 6551360, 6551386, 6551345, 6552160, 6552152, 6551394 DR3500: 6553101, 6553127, 6553119, 6553143, 6553135, 6553036, 6553093

Product
Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for examination of…
Recalling firm
Carestream Health, Inc.
Quantity
79
Distribution
Worldwide distribution in the sate of Iowa and countries of Italy, China, Spain, and Austria.
Recall date
January 22, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls