PlainRecalls
FDA Devices Moderate Class II Terminated

The GC80 Digital X-ray Imaging System

Reported: March 14, 2018 Initiated: June 22, 2017 #Z-0726-2018

Product Description

The GC80 Digital X-ray Imaging System

Reason for Recall

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

Details

Recalling Firm
NeuroLogica Corporation
Units Affected
45 units
Distribution
Nationwide US
Location
Danvers, MA

Frequently Asked Questions

What product was recalled?
The GC80 Digital X-ray Imaging System. Recalled by NeuroLogica Corporation. Units affected: 45 units.
Why was this product recalled?
An image was obtained with over exposure during a Thorax examination using the AEC function.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 14, 2018. Severity: Moderate. Recall number: Z-0726-2018.