FDA Enforcement
Class II
Terminated
The GC80 Digital X-ray Imaging System
Recall: Z-0726-2018
·
Reported March 14, 2018
Enforcement
- Recall Number
- Z-0726-2018
- Event ID
- 78679
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- NeuroLogica Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 14, 2018
- Initiation Date
- June 22, 2017
- Classification Date
- March 2, 2018
- Termination Date
- October 5, 2018
- Address
- 14 Electronics Ave, N/A, Danvers, MA, 01923-1011, United States
Description
The GC80 Digital X-ray Imaging System
Reason
An image was obtained with over exposure during a Thorax examination using the AEC function.
Code Info
Accession Number 1310459
Distribution
Nationwide US
Quantity
45 units