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U.S. Department of Health and Human Services

Class 2 Device Recall Ysio

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  Class 2 Device Recall Ysio see related information
Date Initiated by Firm January 31, 2022
Create Date March 30, 2022
Recall Status1 Open3, Classified
Recall Number Z-0841-2022
Recall Event ID 89703
510(K)Number K081722  
Product Classification System, x-ray, stationary - Product Code KPR
Product Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system
Code Information Serial Numbers: 20113 23071 20118 22523 23021 22169 23164 22388 22119 22844 21209 23699 21114 22190 22146 22126 22128 22836 22163 22727 22135 22347 21174 22676 22029 22895 22917 22920 22058 22847 22852 22655 22708 22275 22254 22928 22857 22208 22071 23130 22092 22175 21194 23602 23018 23019 22076 22630 21108 22919 22825 22054 22177 20105 22998 20115 22104 22966 23625 23627 22748 22352 22353 22354 22618 21004 21005 22136 23059 22914
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Anastasia Sokolova
610-219-4834
Manufacturer Reason
for Recall		 Siemens Healthineers has identified a software error in previous software version VB10 for the Ysio fully automated system. The unit may process incorrect internal values for the position of its ceiling tube stand. If the user activates a longitudinal or transversal movement at the time of the error, the system controls may initiate a correction of the tube stand position, resulting in an unintended movement. If the described error occurs, a potential for collision risk for objects or persons in the vicinity of the moving stand exists. This may result in minor to serious injuries to persons.
FDA Determined
Cause 2		 Software design
Action An URGENT: MEDICAL DEVICE CORRECTION dated 1/31/22 was sent to customers. What is the impact on system operation and what are the potential risks? If the described error occurs, a potential for collision risk for objects or persons in the vicinity of the moving stand exists. This may result in minor to serious injuries to persons. What steps can the user take to avoid the potential risks associated with this issue? It is highly improbably that the user will experience the described issue. However, it is recommended to follow regular cautions and instructions listed in the system operator manual, particularly in the chapter Safety , section Information about unit movements . Users and all accompanying personnel are advised to remain outside the zone of potential device movement, e.g., potential movement area of longitudinal and transversal direction of the ceiling stand. How will the corrective action be implemented and how effective is the corrective action? Siemens Healthineers is distributing a Customer Safety Advisory Letter XP046/20/S to all affected customers. A field software update for Ysio units that will eliminate the described issue will be distributed via an Update Instruction XP045/20/S. Apart from the described correction, the updated software contains further stability, usability, and performance improvements. This resolution will be provided free of charge and is planned to be available in the first quarter of calendar year 2022. Your local Siemens Healthineers Service organization will contact you as soon as the software update is available for your system. Please feel free to contact our service organization for an earlier appointment at 1-800- 888-7436. Following the corrective action, the cause is eliminated and any recurrence of this potential fault is prevented Acknowledge Receipt of this Safety Advisory Notice Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisor
Quantity in Commerce 70 Systems
Distribution US Nationwide.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KPR and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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