Recall Z-0015-2017 ยท KPR System, X-Ray, Stationary
Siemens Medical Solutions USA, Inc
YSIO Max Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max 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, punctures, etc.) and emergency
| Date | Aug 1, 2016 |
| Status | Terminated |
| Reason | Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion systems. There is an unlikely risk that an internal part of the table may detach causing the table top to tilt to the left side which could result in an injury to a patient on the table. |
| Root cause | Process control |
| Action | Siemens sent a Customer Safety Advisory Notice letter dated August 4, 2016 to their customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to discontinue use of the tables until one of their service technicians can inspect the affected part of each table. |
| Quantity | 37 Systems |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133259 | YSIO MAX Siemens Medical Solutions USA, Inc., Jan 24, 2014 |