Z-2128-2020 Class II Terminated
FDA device recall Z-2128-2020 was initiated by Siemens Medical Solutions USA, Inc on April 17, 2020 and is designated Class II. Reason for recall: 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 recall status is terminated (terminated August 25, 2020). Affected quantity: 20.
Recall Details
- Product Type
- Devices
- Report Date
- June 3, 2020
- Initiation Date
- April 17, 2020
- Termination Date
- August 25, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20
Product Description
Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194
Reason for Recall
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.
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.
Code Information
Serial Numbers: 50135 50131 50171 50129 50048 50184 50180 50136 50185 50153 50155 50130 50127 50134 50166 50192 50161 50128 50132 50160