Samsung GU60A system- Digital X-ray Imaging Systems are recall
Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained…
Why was Samsung GU60A system- Digital X-ray Imaging Systems are recalled?
When performing the Stitching function on GU60A system, unintended area is exposed to radiation
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained…
- Recalling firm
- NeuroLogica Corporation
- Quantity
- 87 units
- Distribution
- Nationwide Distribution
- Recall date
- September 6, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)