Recall Z-0782-2020 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Cios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical application
| Date | Jan 7, 2020 (initiated Nov 25, 2019) |
| Status | Terminated |
| Reason | During a routine inspection of a system, a crack on the C-arm holder was discovered. In the event the C-arm holder has a crack, the stability of the C-arm may be compromised and could lead to deformations of the C-arm. In very unlikely cases, an extreme impact to the C-arm such as heavy collision with a wall or table, may lead to a detachment of the C-arm and could potentially result in injury to patients and staff. |
| Root cause | Nonconforming Material/Component |
| Action | An Urgent Medical Device Correction notification letter dated 11/25/19 was sent to customers. How will the corrective action be implemented and what is the efficiency of the corrective actions? To verify that your system is not affected by this problem, a visual inspection will be carried out by trained service staff. If no crack is found during the visual inspection, the C-arm can be used again in its original functionality in patient operation. Should a non-conformity be found and require repair, your device will be sent to the manufacturer and an equivalent loan device will be provided |
| Quantity | 190 (updated total of 202 as of 1/20/20) |
| Distribution | US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, 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 |