Recall Z-2127-2020 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10308191 and VA30-10308194 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.
| Date | May 4, 2020 (initiated Apr 17, 2020) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | URGENT: MEDICAL DEVICE CORRECTION notification letters dated 4/17/20 were sent to customers. What is the impact to the operation of the system and what are the possible risks? There is no impact to the operation of the system, however, unplugging the main cable can cause an unsafe electrical voltage (up to 67,6 V DC) at the X10 connector which can result in an electrical shock if the user or other persons touch the contact pins of the X10 connector. How was the subject identified and what is the root cause? The issue was identified by the manufacturer during system assembly when the plug of |
| Quantity | 58 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181560 | Cios Alpha Siemens Medical Systems USA, Inc., Oct 24, 2018 |