FDAClass IINovember 30, 2016

Merge RadSuite recall

Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31. Advanced Visualization (Image Viewing)…

Why was Merge RadSuite recalled?

It was reported by a customer that RadSuite images are not appearing as readable images. This product malfunction has the potential to result in delay in care and a possible re-exposure of the patient to radiation (x-ray).

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?

RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31

Product
Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31. Advanced Visualization (Image Viewing)…
Recalling firm
Merge Healthcare, Inc.
Quantity
29
Distribution
Nationwide Distribution including AL, CA, FL,IN, MI, MO, NY, PA, TN, and WI.
Recall date
November 30, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls