Recall Z-1501-2020 ยท KPR System, X-Ray, Stationary
Siemens Medical Solutions USA, Inc
Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.
| Date | Mar 3, 2020 (initiated Feb 10, 2020) |
| Status | Terminated |
| Reason | The Ysio system may process incorrect internal values for the position of its ceiling tube stand. If in this situation the user activates longitudinal or transversal stand movement (by using the buttons at the tube head or the remote console), the systems controls may (depending on the values being processed) initiate a correction of the tube stand position, resulting in an unexpected movement. |
| Root cause | Component design/selection |
| Action | On February 10, 2020, the firm notified affected customers via Urgent Medical Device Correction letters. Customers were informed of the product issue, and instructed to take the following actions: When using the system, users should follow the regular cautions and instructions listed in the system operator manual, particularly in chapter Safety, section Information about unit movements. In addition, users and all accompanying personnel are to pay special attention to remain outside of the zone of potential device movement (hazardous zone), e.g., remain outside the possible movement area of l |
| Quantity | 81 US/ 308 worldwide |
| Distribution | US Nationwide distribution in the states of AR, CA, DC, FL, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, SC, TX, UT, VA and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081722 | YSIO Siemens Medical Solutions USA, Inc., Aug 22, 2008 |