FDAClass IIMarch 14, 2018

The GC80 Digital X-ray Imaging System recall

The GC80 Digital X-ray Imaging System

Why was The GC80 Digital X-ray Imaging System recalled?

An image was obtained with over exposure during a Thorax examination using the AEC function.

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?

Accession Number 1310459

Product
The GC80 Digital X-ray Imaging System
Recalling firm
NeuroLogica Corporation
Quantity
45 units
Distribution
Nationwide US
Recall date
March 14, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls