Devices

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
Manufacturer
NeuroLogica Corporation
1 Event
- Recall of Device Recall Samsung GU60A system Digital Xray Imaging Systems

Manufacturer

NeuroLogica Corporation

Manufacturer Address
NeuroLogica Corporation, 14 Electronics Ave, Danvers MA 01923-1011
Manufacturer Parent Company (2017)
Samsung Electronics Co., Ltd.
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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