Class 2 Device Recall Ysio

• Date Initiated by Firm: February 10, 2020
• Date Posted: March 03, 2020
• Recall Status: Terminated on August 31, 2020
• Recall Number: Z-1501-2020
• Recall Event ID: 85029
• 510(K)Number: K081722
• Product Classification: System, x-ray, stationary - Product Code KPR
• Product: Ysio, model no. 10281013; ; Product Usage: The product is a stationary X-Ray system.
• 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
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355-1418
• For Additional Information Contact: Customer Service; 800-888-7436
• Manufacturer 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.
• FDA Determined 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 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.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KPR and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.