FDA recall Z-0726-2018
NeuroLogica Corporation · Class II · device
Product
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
Nationwide US
Key facts
- Status
- Terminated
- Initiation date
- 2017-06-22
- Report date
- 2018-03-14
- Termination date
- 2018-10-05
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Danvers, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0726-2018