Z-1346-2021Class II

Ysio X.pree, Model Number: 11107464 -

Name: Z-1346-2021 Ysio X.pree, Model Number: 11107464 -
Creator: Siemens Medical Solutions USA, Inc
Published: 2021-03-10
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2021-03-10 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of 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... on 2021-03-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1346-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-10
Posted: 2021-04-02
Terminated: 2023-12-11
Recalling firm: Siemens Medical Solutions USA, Inc.
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.
Product code: KPR System, X-Ray, Stationary
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
Root cause tag: design
FDA root 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.
Product codes and lots: Serial Numbers: 10041 10046 10055 10057 10053 10049 10043 10039 10054 10048 10042 10045

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1346-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1346-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-14	2021-04-02

Product code KPR

K201670Class IIYSIO X.preeSiemens Medical Solutions USA, Inc. / cleared 2020-10-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)