Home / Recalls / Siemens Medical Solutions USA, Inc / Z-0841-2022

Z-0841-2022 Class II Ongoing

Recalled by Siemens Medical Solutions USA, Inc — Malvern, PA

FDA device recall Z-0841-2022 was initiated by Siemens Medical Solutions USA, Inc on Jan 31, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 70 Systems.

Recall Details

Product Type: Devices
Report Date: Apr 6, 2022
Initiation Date: Jan 31, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 70 Systems

Product Description

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

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.

Distribution Pattern

US Nationwide.

Code Information

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0841-2022
openFDA file date: Oct 26, 2026
Loaded by RegDataLab: Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.