FDA-Device2020-05-20Class II
Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The 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
Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any time during clinical session. If the system displays the error message Err 16305 / 80, the unplugging of the main cable can cause an unsafe electrical voltage (125 V DC) at the X10 connector and result in an electrical shock if the user or other persons touch the contact pins of the X10 connector. These contact pins are accessible when the main cable is unplugged from the X10 connector
Sold states
US Nationwide distributions.
Affected count
4 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The 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-1957-2020Don't want to check this manually?
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