Z-0841-2022Class II

Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system

Name: Z-0841-2022 Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system
Creator: Siemens Medical Solutions USA, Inc
Published: 2022-01-31
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2022-01-31 / Open, Classified / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system on 2022-01-31. FDA classified it as Class II and gives the reason as "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...". 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-0841-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-01-31
Posted: 2022-03-30
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system
Product code: KPR System, X-Ray, Stationary
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.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0841-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0841-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-06	2022-03-30

Product code KPR

K081722Class IIYsioSiemens Medical Solutions USA, Inc. / cleared 2008-08-22

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)