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Terminated

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.

FDA Recall Z-1346-2021 · Posted None

Recall StatusTerminated
Product CodeKPR
Date Initiated2021-03-10
Date Terminated2023-12-11
Product Quantity12 units

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

Firm 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.

Root Cause

Device Design

Distribution Pattern

US Nationwide distribution in the states of FL, MN, OH, PA, TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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