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Devices
Device Recall AXIOM SIRESKOP SD, SIRESKOP SX, AXIOM LUMINOS
Model / Serial
Model Numbers: 3111668, 3111676, 8890407, 8890415, and 10093902
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution including AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY.
Product Description
AXIOM SIRESKOP SD, SIRESKOP SX, AXIOM LUMINOS || System, X-Ray, Fluoroscopic, image-intensified; solid state x-ray imager (flat panel/digital imager)
Manufacturer
Siemens Medical Solutions USA, Inc
1 Event
Recall of Device Recall AXIOM SIRESKOP SD, SIRESKOP SX, AXIOM LUMINOS
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Manufacturer
Siemens Medical Solutions USA, Inc
Manufacturer Address
Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
Manufacturer Parent Company (2017)
Siemens Ag
Source
USFDA
Language
English
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