Recall Z-1717-2014 ยท KPR System, X-Ray, Stationary
Siemens Medical Solutions USA, Inc
Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems are radiographic systems used in hospitals, clinics, and medical practices. Ysio enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy,
| Date | Jun 4, 2014 (initiated May 9, 2014) |
| Status | Terminated |
| Reason | Excessive usage of cleaning liquid on Siemens Ysio Systems may cause infiltration of the generator console, which may lead to a short circuit causing an unintended release of radiation. |
| Root cause | Use error |
| Action | Siemens sent an Safety Advisory Notice letter dated May 9, 2014, to affected customer. The letter identified the affected product, problem and actions to be taken. For question call +49 (913) 84-9908. |
| Quantity | 433 |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081722 | YSIO Siemens Medical Solutions USA, Inc., Aug 22, 2008 |