Z-0726-2018 Class II Terminated
FDA device recall Z-0726-2018 was initiated by NeuroLogica Corporation on June 22, 2017 and is designated Class II. Reason for recall: An image was obtained with over exposure during a Thorax examination using the AEC function. The recall status is terminated (terminated October 5, 2018). Affected quantity: 45 units.
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