Class 2 Device Recall Siemens Healthineers

• Date Initiated by Firm: March 10, 2021
• Create Date: April 02, 2021
• Recall Status: Terminated on December 11, 2023
• Recall Number: Z-1346-2021
• Recall Event ID: 87563
• 510(K)Number: K201670
• Product Classification: System, x-ray, stationary - Product Code KPR
• Product: Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from the whole body including the skull, chest, abdomen, and extremities.
• Code Information: Serial Numbers: 10041 10046 10055 10057 10053 10049 10043 10039 10054 10048 10042 10045
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355
• For Additional Information Contact: SAME; 610-219-4834
• Manufacturer Reason for Recall: A patient image was assigned to a different patient during image recovery process. In the unlikely event of interrupted connection to a MAX detector during initiated image recovery, instead of the currently acquired image, previously acquired image (potentially image of the previous patient) may be displayed to the user, potentially impact diagnosis of the patient examined when the connection was interrupted
• FDA Determined Cause: Device Design
• Action: Siemens Medical Solutions USA, Inc. issued Customer Safety Advisory Notice to customers via XP051/20/S on 3/10/21. Letter states reason for recall, health risk and action to take: It is advised for the user to check the image displayed following image recovery to ensure that it is a newly acquired image of the current patient. If the operator detects the error, the image should be deleted, and Siemens Customer Service should be notified. Siemens Healthineers will provide a field software update VA10D for YSIO X.pree units that will eliminate the issue described. The software update will be disturbed to all potentially affected users via an Update Instruction XP052/20/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 will be available in the second quarter of calendar year 2021. 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. Additionally, a software solution VA10D to eliminate the root cause of this problem will be distributed via XP052/20/S. Following the corrective action, the cause is eliminated and a recurrence of the fault is prevented.
• Quantity in Commerce: 12 units
• Distribution: US Nationwide distribution in the states of FL, MN, OH, PA, TX.
• 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.