PlainRecalls
FDA Devices Moderate Class II Terminated

Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.

Reported: March 25, 2020 Initiated: February 10, 2020 #Z-1501-2020

Product Description

Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.

Reason for Recall

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.

Details

Units Affected
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.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 81 US/ 308 worldwide.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 25, 2020. Severity: Moderate. Recall number: Z-1501-2020.