FDA Devices recall · Reported April 6, 2022
Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system
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 …
Siemens Medical Solutions USA, Inc recalled Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system - a moderate-severity action.
Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system was recalled by Siemens Medical Solutions USA, Inc in April 6, 2022. Reason: Siemens Healthineers has identified a software error in previous software version VB10 for the Ysio fully aut…. Check the official notice for the remedy. Verify recall #Z-0841-2022 with the FDA Devices before acting.
The recall
Siemens Medical Solutions USA, Inc issued this moderate-severity FDA Devices recall-Siemens Healthineers has identified a software error in previous software version VB10 for the Ysio fully aut….
- Moderate
- severity level
- Class II
- classification
- April 6, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0841-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0841-2022 |
| Date reported | April 6, 2022 |
| Date initiated | January 31, 2022 |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Firm location | Malvern, PA |
| Affected scope | 70 Systems |
| Distribution | US Nationwide. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0841-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026