About the database
How to use the database
Download the data
FAQ
Credits
Manufacturers
NeuroLogica Corporation
Manufacturer Address
NeuroLogica Corporation, 14 Electronics Ave, Danvers MA 01923-1011
Manufacturer Parent Company (2017)
Samsung Electronics Co., Ltd.
Source
USFDA
4 Events
Recall of Samsung GM60A40S
Recall of Device Recall GMR40
Recall of Device Recall GC80 Digital Xray Imaging System
Recall of Device Recall Samsung GU60A system Digital Xray Imaging Systems
{{ $t('card.reduce') }}
{{ $tc('card.more', left) }}
4 devices in the database
Samsung GM60A40S
Model / Serial
Serial Numbers: 50EAM9BG200004X, 50EAM9BG200001A 50EAM9BG200002P, 50EAM9BG200003D, 50EAM9BG200005N, 50EAM9BG200006E, 50EAM9BG200007F
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Distributed to the states of NC, OH, MA, and MO.
Product Description
Samsung GM60A-40S || Intended for use in generating radiographic images of human anatomy.
Device Recall GMR40
Model / Serial
Model Number GMR40. Serial numbers 00001 through 00016.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
US Distribution . Only one consignee was shipped 16 units of the affected device.
Product Description
Solid state x-ray imager (flat panel/digital imager) || Solid state x-ray imager (flat panel/digital imager) || Medical
Device Recall GC80 Digital Xray Imaging System
Model / Serial
Accession Number 1310459
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide US
Product Description
The GC80 Digital X-ray Imaging System
Device Recall Samsung GU60A system Digital Xray Imaging Systems
Model / Serial
Serial Numbers: S03PM3ADA00001T S03PM3ADC00001H S03PM3ADC00002J S03PM3AF200004X S03PM3AF200005N S03PM3AF200006E S03PM3AF300001K S03PM3AF300002Z S03PM3AF300007X S08HM3AF300001J S08HM3AF300002B S08HM3AF300004H S08HM3EF400001W S08HM3EF400002A S08HM3DF400002Y S08HM3EF400003H S08HM3EF400004K S08HM3DF400003R S08HM3DF400004B S08HM3EF400005E S08HM3DF500001B S08HM3CF500001T S08HM3EF500001K S08HM3DF500002F S08HM3BF500001L S08HM3BF500002N S08HM3CF600001R S08HM3CF600003V S08HM3DF600002P S08HM3DF600001H S08HM3DF600003L S08HM3DF600004F S08HM3DF600005Y S08HM3DF600006W 508UM3BF700001L S08HM3AFB00001Y 508UM3BG100002K 508UM3BG100001T 50FFM3AG200001V 50FFM3AG200002K 50FFM3AG200003P 50FFM3AG200004E 50FFM3AG200005J 50FFM3AG300001X 50FFM3BG600003E 50FFM3BG600002V 50FFM3BG600001A 50FFM3CG700004E 50FFM3CG700002B 50FFM3CG700003M 50FFM3CG700001P 50FFM3CG700006T 50FFM3CG700007J 50FFM3CG700005A 50FFM3CG700008N 50FFM3AG700002L 50FFM3AG700001Y 50FFM3AG800004K
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution
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
Language
English
Français
Español
한국어