Recall Z-3036-2017— NeuroLogica Corporation
Class II · Terminated
Class II FDA medical device recall by NeuroLogica Corporation, initiated 2017-05-24, terminated 2018-07-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. Reason: When performing the Stitching function on GU60A system, unintended area is exposed to radiation.
- Recalling firm
- NeuroLogica Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-24
- Terminated
- 2018-07-09
- Firm location
- Danvers, MA, United States
Product description
Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications
Reason for recall
When performing the Stitching function on GU60A system, unintended area is exposed to radiation
Data sourced from openFDA. This site is unofficial and independent of the FDA.