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Devices
Device Recall Varian Medical Systems VARiS
Model / Serial
Version Numbers 6.2.27 and 6.2.35, 510k number K001643, serial numbers H8__ (31901, 50044, 50149, 50181, 50187,50260, 50284, 50315, 50357, 50397, 50430, 50804, 50873, 51096, 51152, 51186, 51082, 51463, 51534, 51580, 51658, 51773, 51787, 59032, 59040, 59041, 59045)
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
produt was distributed to 28 medical facilities, 12 in the United states, 16 foreign
Product Description
medical device and software systems
Manufacturer
Varian Medical Systems Inc
1 Event
Recall of Device Recall Varian Medical Systems VARiS
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Manufacturer
Varian Medical Systems Inc
Manufacturer Address
Varian Medical Systems Inc, 3100 Hansen Way, Palo Alto CA 94304-1028
Source
USFDA
Language
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