Devices

Device Recall ARTIS Pheno Interventional Fluoroscopic XRay System

Model / Serial
164033 164071 164034 164095 164057 164055 164054 164080 164072 164088 164048 164094 164068 164019 164013 164073 164027 164026 164025 164060 164083 164021 164066 164075 164084 164086 164074 164098 164028 164053 164063 164064 164024 164049 164022 164018 164100 164097 164011
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Healthcare facilities in AL, CA, CO, FL, IL, KY, MA, MI, MN, MS, NE, NJ, NY, OH, TN, TX, UT, and VA. Foreign distribution to Australia, Austria, Belgium, Denmark, France, Germany, Italy, Japan, Kuwait, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.
Product Description
ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000
Manufacturer
Siemens Medical Solutions USA, Inc
1 Event
- Recall of Device Recall ARTIS Pheno Interventional Fluoroscopic XRay System

Manufacturer

Siemens Medical Solutions USA, Inc

Manufacturer Address
Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Malvern PA 19355-1418
Manufacturer Parent Company (2017)
Siemens Ag
Source
USFDA

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