Recall Z-1278-2016 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Cios Alpha, mobile X-ray system
| Date | Mar 31, 2016 (initiated Feb 19, 2016) |
| Status | Terminated |
| Reason | Software issues on Cios Alpha mobile C-Arm system |
| Root cause | Software in the Use Environment |
| Action | Siemens sent an Customer Safety Advisory Notice on February 26, 2016, to inform them of some issues that may arise on the Cios Alpha unit. The letter identified the product the problem and the action needed to be taken by the customer. Users were instructed to change the date format to DDMMYYYY to prevent issues, not to release radiation as long as the DVD icon is blinking and to disconnect and re-connect the trolley if the system is needed immediately. In the meantime they are preparing a modification of Cios Alpha that will resolve the above-mentioned issues. As soon as the modificatio |
| Quantity | 89 systems |
| Distribution | Nationwide Distribution to the states of : AL, AR, CA, CO, CT, DE, FL, GA, IA, IL, KY, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, WA and WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132094 | CIOS ALPHA Siemens Medi Cal Solutions, Inc., Mar 11, 2014 |