Skip to content
Recall Observatory FDA recall evidence

Device product

Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194

Z-2128-2020

April 17, 2020

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 85572
Status
Terminated
Classification
Class II
Quantity
20
Official record key
device-enforcement:Z-2128-2020

Official wording

Reason: The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsafe electrical voltage (up to 67,6 V DC) at the X10 connector. This can result in an electrical shock if the user or other persons touch the contact pins of the X10 connector.

Code information: Serial Numbers: 50135 50131 50171 50129 50048 50184 50180 50136 50185 50153 50155 50130 50127 50134 50166 50192 50161 50128 50132 50160

Distribution pattern: US Nationwide Distribution to states of: AR, AZ, CA, FL, IL, IN, MA, MD, MI, MN, NC, NE, NH, NJ, NY, OH, OK, SC, TN, TX, UT, VA, WA, and Puerto Rico.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsafe electrical voltage (up to 67,6 V DC) at the X10 connector. This can result in an electrical shock if the user or other persons touch the contact pins of the X10 connector.