Z-0726-2018 Class II Terminated

Recalled by NeuroLogica Corporation — Danvers, MA

Recall Details

Product Type
Devices
Report Date
March 14, 2018
Initiation Date
June 22, 2017
Termination Date
October 5, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
45 units

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.

Distribution Pattern

Nationwide US

Code Information

Accession Number 1310459