Recall Z-0726-2018— NeuroLogica Corporation
Class II · Terminated
Class II FDA medical device recall by NeuroLogica Corporation, initiated 2017-06-22, terminated 2018-10-05. It names one FDA 510(k) clearance: K143029. Product: The GC80 Digital X-ray Imaging System. Reason: An image was obtained with over exposure during a Thorax examination using the AEC function..
- Recalling firm
- NeuroLogica Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-22
- Terminated
- 2018-10-05
- Firm location
- Danvers, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.