—#179938

Product

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

FDA product code: KPR — System, X-Ray, Stationary
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K081722
Affected lot / code info: 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

Why it was 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.

Root cause (FDA determination)

Component design/selection

Action the firm took

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 longitudinal and transversal direction of the ceiling stand. Siemens Healthineers has issued a field software update that will eliminate the issue described. The resolution will be provided free of charge. The software update is already available and is being distributed. Your local Siemens Healthineers Service organization will contact you to schedule the software update for your system. To schedule an earlier appointment, you may contact the firm's service organization at 1-800-888-7436.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

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.

Timeline

Recall initiated: 2020-02-10
Posted by FDA: 2020-03-03
Terminated: 2020-08-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179938. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.