FDA recall Z-2128-2020

Product

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

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.

Key facts

Status

Terminated

Initiation date

2020-04-17

Report date

2020-06-03

Termination date

2020-08-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2128-2020