Z-0730-2022Class II

YSIO X.Pree

Name: Z-0730-2022 YSIO X.Pree
Creator: Siemens Medical Solutions USA, Inc
Published: 2022-03-07
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2022-03-07 / Open, Classified / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of YSIO X.Pree on 2022-03-07. FDA classified it as Class II and gives the reason as "For the automated multi-image-acquisition procedure Ortho x-ray collimation is set in a preparative stage for the entire examination area prior to the exam. During acquisition of each individual x-ray image, the x-ray...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0730-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-07
Posted: 2022-04-05
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: YSIO X.Pree
Product code: KPR System, X-Ray, Stationary
Reason for recall: For the automated multi-image-acquisition procedure Ortho x-ray collimation is set in a preparative stage for the entire examination area prior to the exam. During acquisition of each individual x-ray image, the x-ray collimator is automatically positioned in a way that the subsequent series of acquisition covers the defined field of view needed for each step. However, during the acquisition the collimation area displayed to the operator on the User Interface does not correctly represent the collimation area specified by the system. It indicates to the user an open collimator instead, e.g., the information displayed on the User Interface shows wider area of collimation than values preset prior to the examination. However, the collimation of the x-ray is performed correctly and always matches the examination area predefined by the user.
Root cause tag: software
FDA root cause: Software design
Action: Siemens Medical Solutions USA, Inc. has initiated a Customer Advisory Notice to all affected customers. The letter inform customers that the firm will distribute a software correction via update instruction at no cost to the customers.
Quantity in commerce: 53 units
Distribution: US Nationwide, Worldwide distribution
Product codes and lots: 11107464

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0730-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0730-2022	Class II	Ongoing	FDA Mandated	2022-04-13	2022-04-05

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)