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Devices
Varian Medical System TrueBeam
Model / Serial
Model number H19; Code numbers: H191011, H191019, H191027, H191033, H191012, H191021, H191028, H191037, H191013, H191023, H191030, H191043, H191016, H191025, H191031, H191045, H191018, H191026, H191032, H191047. Affected NDA Serial numbers: P7-03112, P7-03174, P7-03221.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide distribution.
Product Description
Varian Medical System TrueBeam system for stereotactic radiosurgery and radiotherapy. Model number H19;
Manufacturer
Varian Medical Systems, Inc. Oncology Systems
1 Event
Recall of Varian Medical System TrueBeam
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Manufacturer
Varian Medical Systems, Inc. Oncology Systems
Manufacturer Address
Varian Medical Systems, Inc. Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
Manufacturer Parent Company (2017)
Varian Medical Systems Inc
Source
USFDA
Language
English
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