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Devices
POLYSTAR T.O.P. XRay System
Model / Serial
Serial Numbers for model 1148902: 01000 through 01267, 02001 through 02117. Serial numbers for model4784505: 03001 through 035158, 04001 through 04136, and 05001 through 05098
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
The product was shipped to medical facilities nationwide and government accounts in KS and MI.
Product Description
POLYSTAR T.O.P., Angiographic X-Ray System, Model || Numbers 1148902 and 4784505.
Manufacturer
Siemens Medical Solutions USA, Inc
1 Event
Recall of POLYSTAR T.O.P. XRay System
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Manufacturer
Siemens Medical Solutions USA, Inc
Manufacturer Address
Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355-1406
Manufacturer Parent Company (2017)
Siemens Ag
Source
USFDA
Language
English
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