Device product
Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.
Z-1501-2020
Product summary
- Event
- Event 85029
- Status
- Terminated
- Classification
- Class II
- Quantity
- 81 US/ 308 worldwide
- Official record key
device-enforcement:Z-1501-2020
Official wording
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.
Code information: Serial Nos. 20113 20034 21100 21086 21113 21088 21103 21221 21223 21224 21085 20045 20093 20110 21066 21031 21139 21006 20155 21112 21122 21185 20088 20089 20106 20107 21052 21089 21213 20167 21098 21174 21057 21101 21116 21117 21118 21120 21091 21092 21037 21076 21077 21200 21203 21209 20149 21163 21172 21171 21173 20094 21115 20047 21194 20193 21211 21212 21186 21188 21094 21039 21040 21108 20035 20185 21061 21065 21205 21095 21148 21189 21140 21175 21023 21001 21127 21123 21013 20159 21160
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.