FDA-Device2020-09-02Class II
Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications
Siemens Medical Solutions USA, Inc
Hazard
Hardware error- Hot Plugging feature could cause an electrical malfunction on the main control D80 (below revision 04 installed) of the generator which is part of the main unit (c-arm) and cause permanent loss of imaging functionality.
Sold states
Nationwide
Affected count
US: 282 units; OUS: 1363
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2848-2020Don't want to check this manually?
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